Study of Shunt Flow Under Different Valve Settings Using a Wireless Sensor

NCT07679035 | Not Yet Recruiting FDA Device

• 1 other identifier: 2026-01
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 1

Brief Summary

Hydrocephalus is commonly treated with a cerebrospinal fluid (CSF) shunt, a device that drains excess fluid from the brain. However, shunts can stop working over time, and determining whether fluid is flowing through a shunt can be difficult. Current diagnostic methods may require imaging studies or invasive procedures, which can be time-consuming, costly, or uncomfortable for patients. The purpose of this study is to evaluate the performance of the Rhaeos Shunt Monitoring System (RSMS), an investigational wireless, noninvasive device designed to detect flow in implanted CSF shunts. The study will compare RSMS directly with ShuntCheck III, an FDA-cleared noninvasive device that is also used to assess CSF shunt flow. Both devices are placed on the skin over the shunt and use thermal sensing technology to evaluate whether fluid is flowing through the shunt. Approximately 85 pediatric and adult participants with an existing ventricular CSF shunt will be enrolled. Participants must have a functioning shunt and no recent symptoms suggesting shunt malfunction. Some participants with programmable shunt valves will have their valve temporarily adjusted to a manufacturer-provided "virtual off" setting, which is intended to substantially restrict shunt flow. These participants may also undergo measurements at their normal valve setting. Other participants will only undergo measurements at their normal valve setting. During the study visit, participants will undergo shunt flow assessments with both RSMS and ShuntCheck III. The order in which the devices are used will be randomized. Device measurements are collected while participants are seated upright, and participants and their treating clinicians will remain blinded to the measurement results. The study devices will not be used to make treatment decisions, and participation will not alter standard medical care. Adverse events associated with device use or valve adjustments will be monitored and recorded. The primary goal of the study is to compare the ability of RSMS and ShuntCheck III to correctly identify shunts with flow-permissive ("valve normal") and restricted-flow ("virtual off") settings. Results from this study may help support the future development of a noninvasive tool to aid neurosurgeons in assessing CSF shunt flow. Participants are not expected to receive a direct medical benefit from taking part in the study.

Conditions

Hydrocephalus

Keywords

shunt; csf; cerebrospinal fluid; rhaeos; VP shunt

Outcome Measures

Primary Outcomes (2)

• Sensitivity of the Rhaeos Shunt Monitoring System Compared With ShuntCheck III

  Sensitivity of the investigational Rhaeos Shunt Monitoring System (RSMS) compared with the FDA-cleared predicate device (ShuntCheck III) for identifying non-flowing cerebrospinal fluid shunts during the "virtual off" valve setting. Sensitivity is calculated as the proportion of "virtual off" measurements correctly identified as "flow not confirmed."

  Day 1 (study visit)

• Specificity of the Rhaeos® Shunt Monitoring System Compared With ShuntCheck III

  Specificity of the investigational Rhaeos Shunt Monitoring System (RSMS) compared with the FDA-cleared predicate device (ShuntCheck III) for identifying flow-permissive cerebrospinal fluid shunts during the prescribed "valve normal" setting. Specificity is calculated as the proportion of flow-permissive measurements correctly identified as "flow confirmed."

  Day 1 (study visit)

Study Arms (1)

Participants Undergoing Paired CSF Shunt Flow Assessment

OTHER

Participants undergo paired, noninvasive assessment of cerebrospinal fluid (CSF) shunt flow using both the investigational Rhaeos® Shunt Monitoring System (RSMS) and the FDA-cleared predicate device, ShuntCheck III. The order of device use is randomized for each participant. All participants are evaluated at their prescribed flow-permissive ("valve normal") shunt setting. Participants with programmable shunt valves that can be adjusted to a manufacturer-reported "virtual off" setting also undergo measurements after temporary adjustment to the "virtual off" setting, followed by return of the valve to the prescribed setting. Device results are blinded to participants and treating clinicians and are not used for clinical decision-making. Adverse events are monitored throughout study participation.

Device: Rhaeos Shunt Monitoring System (RSMS); Device: ShuntCheck III

Interventions

Rhaeos Shunt Monitoring System (RSMS) DEVICE

The Rhaeos Shunt Monitoring System (RSMS) is an investigational, wireless, noninvasive thermal flow detection device that is applied to the skin overlying an implanted cerebrospinal fluid (CSF) shunt. The device uses controlled thermal energy and temperature sensors to detect thermal patterns associated with CSF flow. Measurements are obtained using a tablet application, and device results are encoded to maintain blinding. The device is used for research purposes only and is not used to guide clinical care.

Participants Undergoing Paired CSF Shunt Flow Assessment

ShuntCheck III DEVICE

ShuntCheck III is an FDA-cleared, noninvasive thermal flow detection device used as the predicate comparator. The device uses transcutaneous thermal dilution produced by an instant cold pack and a disposable thermosensor array applied over the implanted CSF shunt to detect shunt flow. Measurements are obtained using the manufacturer's software, and results are encoded to maintain blinding. The device is used for comparison with the investigational device and is not used to guide clinical care during the study.

Participants Undergoing Paired CSF Shunt Flow Assessment

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Existing ventricular cerebrospinal fluid (CSF) shunt. Region of intact skin overlying an unambiguously identifiable, palpable, chronically indwelling ventricular shunt crossing the clavicle and appropriate in size for application of the study device.
• Written informed consent provided by the participant or, when applicable, by a parent, legal guardian, health care agent, or surrogate decision maker according to local regulations.
• For participants with planned "virtual off" measurements:
• Existing ventricular CSF shunt with a programmable valve that has an available manufacturer-reported "virtual off" setting and can be programmed noninvasively.
• For participants whose valve will be adjusted to the "virtual off" setting during the study:
• Subject-reported or documented history of successful shunt valve adjustment(s).

You may not qualify if:

• Presence of more than one distal shunt catheter in the study device measurement region.
• Presence of an open wound or edema in the study device measurement region that would interfere with device placement.
• Shunt difficult to palpate or shunt depth greater than 5 mm from the skin surface at the measurement location as determined by ultrasound.
• Subject-reported or documented history of serious adverse skin reactions to silicone-based adhesives.
• New or worsening symptoms suggestive of shunt malfunction within the previous 7 days.
• Use of the study device would interfere with standard patient care, emergency surgery cannot be delayed, or study participation would interfere with optimal medical care.
• Participation in another investigational procedural, pharmaceutical, or device study that may affect data collected in this study.
• Previous participation in a Rhaeos clinical study using the current-generation RH05-B1 study device.
• For participants with planned "valve normal" measurements only:
• Investigator judges the participant is likely to be shunt independent (e.g., does not require a functional shunt for management of hydrocephalus).
• This format follows ClinicalTrials.gov conventions by separating general criteria from those that apply only to specific participant subgroups.

Sponsors & Collaborators

• Rhaeos, Inc.: lead
• Springfield Clinic: collaborator
• OSF Healthcare System: collaborator
• Johns Hopkins University: collaborator
• SUNY Research Foundation: collaborator
• Northwestern Memorial Hospital: collaborator

Study Sites (1)

Rhaeos, Imc

Chicago, Illinois, 60642, United States

Location

Related Publications (12)

• Xu J, Poole C, Sahyouni R, Chen J. Noninvasive thermal evaluation for shunt failure in the emergency room. Surg Neurol Int. 2019 Dec 27;10:254. doi: 10.25259/SNI_324_2019. eCollection 2019.

  PMID: 31893155 BACKGROUND

• Marlin AE, Gaskill SJ. The use of transcutaneous thermal convection analysis to assess shunt function in the pediatric population. Neurosurgery. 2012 Jun;70(2 Suppl Operative):181-3. doi: 10.1227/NEU.0b013e31823cf18d.

  PMID: 22009251 BACKGROUND

• Kadowaki C, Hara M, Numoto M, Takeuchi K, Saito I. CSF shunt physics: factors influencing inshunt CSF flow. Childs Nerv Syst. 1995 Apr;11(4):203-6. doi: 10.1007/BF00277654.

  PMID: 7621480 BACKGROUND

• Drake JM, Martin AJ, Henkleman RM. Determination of cerebrospinal fluid shunt obstruction with magnetic resonance phase imaging. J Neurosurg. 1991 Oct;75(4):535-40. doi: 10.3171/jns.1991.75.4.0535.

  PMID: 1885970 BACKGROUND

• Madsen JR, Abazi GS, Fleming L, Proctor M, Grondin R, Magge S, Casey P, Anor T. Evaluation of the ShuntCheck noninvasive thermal technique for shunt flow detection in hydrocephalic patients. Neurosurgery. 2011 Jan;68(1):198-205; discussion 205. doi: 10.1227/NEU.0b013e3181fe2db6.

  PMID: 21099708 BACKGROUND

• Madsen JR, Boyle TP, Neuman MI, Park EH, Tamber MS, Hickey RW, Heuer GG, Zorc JJ, Leonard JR, Leonard JC, Keating R, Chamberlain JM, Frim DM, Zakrzewski P, Klinge P, Merck LH, Piatt J, Bennett JE, Sandberg DI, Boop FA, Hameed MQ. Diagnostic Accuracy of Non-Invasive Thermal Evaluation of Ventriculoperitoneal Shunt Flow in Shunt Malfunction: A Prospective, Multi-Site, Operator-Blinded Study. Neurosurgery. 2020 Oct 15;87(5):939-948. doi: 10.1093/neuros/nyaa128.

  PMID: 32459841 BACKGROUND

• Limbrick DD Jr, Skoch J, Auguste K, Grant GA, Lam SK, Tate MC, Langer DJ, Roland JL, Alden TD, Charbel FT, Lober RM, Patten K, Kennedy E, Farless C, Himsworth S, Fasbender R, Lovell-Ewen L, Morales DM, Correia CF, Burton A, Koschnitzky JE, Webb RC, Zysk AM. A Multicenter Study of Noninvasive Wireless Assessment of Cerebrospinal Fluid Shunt Function in Hydrocephalus Patients. Neurosurgery. 2025 Dec 1;97(6):1397-1405. doi: 10.1227/neu.0000000000003569. Epub 2025 Jun 16.

  PMID: 40522244 BACKGROUND

• Webb RC, Ma Y, Krishnan S, Li Y, Yoon S, Guo X, Feng X, Shi Y, Seidel M, Cho NH, Kurniawan J, Ahad J, Sheth N, Kim J, Taylor JG 6th, Darlington T, Chang K, Huang W, Ayers J, Gruebele A, Pielak RM, Slepian MJ, Huang Y, Gorbach AM, Rogers JA. Epidermal devices for noninvasive, precise, and continuous mapping of macrovascular and microvascular blood flow. Sci Adv. 2015 Oct 30;1(9):e1500701. doi: 10.1126/sciadv.1500701. eCollection 2015 Oct.

  PMID: 26601309 BACKGROUND

• Krishnan SR, Ray TR, Ayer AB, Ma Y, Gutruf P, Lee K, Lee JY, Wei C, Feng X, Ng B, Abecassis ZA, Murthy N, Stankiewicz I, Freudman J, Stillman J, Kim N, Young G, Goudeseune C, Ciraldo J, Tate M, Huang Y, Potts M, Rogers JA. Epidermal electronics for noninvasive, wireless, quantitative assessment of ventricular shunt function in patients with hydrocephalus. Sci Transl Med. 2018 Oct 31;10(465):eaat8437. doi: 10.1126/scitranslmed.aat8437.

  PMID: 30381410 BACKGROUND

• Luciano M, Holubkov R, Williams MA, Malm J, Nagel S, Moghekar A, Eklund A, Zwimpfer T, Katzen H, Hanley DF, Hamilton MG; PENS Co-investigators and AHCRN Site PIs. Placebo-Controlled Effectiveness of Idiopathic Normal Pressure Hydrocephalus Shunting: A Randomized Pilot Trial. Neurosurgery. 2023 Mar 1;92(3):481-489. doi: 10.1227/neu.0000000000002225. Epub 2022 Nov 25.

  PMID: 36700738 BACKGROUND

• Holmgren RT, Nilsson M, Georgiopoulos C, Zsigmond P. A Randomized Double-Blinded Clinical Study of Early Volumetric Changes After Shunt Surgery and MRI-Resistance of the Codman Certas(R) Plus Shunt Valve. World Neurosurg. 2025 Oct;202:124424. doi: 10.1016/j.wneu.2025.124424. Epub 2025 Aug 29.

  PMID: 40887008 BACKGROUND

• Krishnan SR, Arafa HM, Kwon K, Deng Y, Su CJ, Reeder JT, Freudman J, Stankiewicz I, Chen HM, Loza R, Mims M, Mims M, Lee K, Abecassis Z, Banks A, Ostojich D, Patel M, Wang H, Borekci K, Rosenow J, Tate M, Huang Y, Alden T, Potts MB, Ayer AB, Rogers JA. Continuous, noninvasive wireless monitoring of flow of cerebrospinal fluid through shunts in patients with hydrocephalus. NPJ Digit Med. 2020 Mar 6;3:29. doi: 10.1038/s41746-020-0239-1. eCollection 2020.

  PMID: 32195364 BACKGROUND

MeSH Terms

Conditions

Hydrocephalus

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Central Study Contacts

Anna L Somera

CONTACT

855-814-3569; info@rhaeos.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2026
• First Posted: July 1, 2026
• Study Start: June 30, 2026
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: July 1, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)