First-In-Human Study of PDT to Detect IAH

NCT06333366 | Recruiting DMC

• 2 other identifiers: 202301590A0C501Application No.2402020052
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

PDT is a continuous pressure monitoring for Intra-Abdominal hypertension (IAH) designed to be less invasive than pan-endoscopic evaluation, more tolerable than abdominal tapping, and more effective than intravesical pressure measurement for IAH. The PDT device consists of a piezoelectric sensor module with a low power Bluetooth wireless transmitter encased in biocompatible capsule. The device will be swallowed after activation. Following PDT insertion, the patient is fitted with a custom, removable external waist accessory containing a receiver, which is worn during monitoring and provide PDT location by signal analysis with sufficient information to provide IAH trends.

Conditions

Intra-Abdominal Hypertension

Keywords

Intra-Abdominal hypertension; Intravesical pressure; Intra-gastrointestinal monitoring device; laparoscopic surgery; Abdominal compartment Syndrome

Outcome Measures

Primary Outcomes (4)

• Incidence of device-related or sensor insertion/removal procedure-related adverse events

  evaluating of incidence of adverse event (AE)

  15 days

• Rate of foreign body reaction due intra-gastrointestinal insertion

  evaluating GI symptoms

  15 days

• Rate of GI symptoms, i.e. inflammation, infection, diarrhea, bowel obstruction, and ileus

  evaluating safety

  15 days

• Incidence of sensor failure

  evaluating stability of device

  15 days

Secondary Outcomes (4)

• Percentage of users feedback in the form of clinical questionnaire to assess the 'easiness' of insertion procedure with questionnaire

  1 day

• Duration of PDT insertion and explantation procedure

  15 days

• Incidence of side effects in Post explantation follow-up

  30 days

• Rate of GI dysfunction after 10 days post explantation of the PDT sensor. Follow-up via phone call after 30 days

  30 days

Other Outcomes (2)

• Rate of sensor ability to measure intra-gastrointestinal pressure (IGP) to allow the development of the algorithm

  5 days

• Incidence of influence of interference substances (i.e. water, saliva, gastric juice, bile, intestinal secretion, feces, and food debris )

  7 days

Study Arms (1)

intraabdominal pressure (IAP) monitor

EXPERIMENTAL

Patient who will take laparoscopic surgery will be checked for intra-abdominal pressure, intra-vesical pressure, and intra-gastrointestinal pressure ri-operative stage. PDT passage time will be checked.

Device: Intra-gastrointestinal monitoring device (PDT)

Interventions

Intra-gastrointestinal monitoring device (PDT) DEVICE

The PressureDOT(PDT) is an active intra-gastrointestinal device, that is intended to be introduced in the gastrointestinal tract, approximately along whole. The device is battery powered. The signal is wirelessly transmitted through outside the body and received by waist receiver, using an antenna array applied to the skin with a protection guard at the level of the abdomen.

intraabdominal pressure (IAP) monitor

Eligibility Criteria

• Age: 20 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patient volunteer planning for laparoscopic surgery
• Subjects willing to sign an informed consent form (ICF),
• Adult subjects, age ≥ 20 and age ≤ 80 years old
• BMI between 15（kg/m2）- 35（kg/m2）
• Subjects willing to comply to study protocol requirements (blood pressure measurement, diet, alcohol, study visits, blood sampling, etc.)
• Patient who had been scheduled for any laparoscopic surgery which may alter intra-abdominal pressure.
• Patient volunteer planning for laparoscopic surgery, as self-declared and confirmed by screening assessments and Principal Investigator's judgment

You may not qualify if:

• Patients with a high risk for capsule retention (such as intestinal diverticula, acute abdominal pain without regular defecation indicating intestinal obstruction or a history of abdominal operation or intestinal reconstructed operation),
• Any evidence that occlusion of gastrointestinal tract is obvious or severe paralytic ileus that may result in intra-abdominal hypertension in need of immediate surgical intervention not caused by base of tongue (i.e., central apnea, neurologic disorder, retropalatal collapse, nasal obstruction)
• Any condition that subject is expected to undergo MRI examination within 7 days after ingestion of the capsule.
• Any factor that, in the surgeon's judgment, would pose a risk to surgery or placement of an intra-gastrointestinal monitoring device
• Any factor that, in the surgeon's judgment, would make the subject unlikely to respond to PDT insertion and pressure measurement.
• Congenital anomalies of gastrointestinal tract or any other anatomical abnormality of the head, neck, chest, or abdomen that would be a contraindication to placement of the PDT device and usage of the external device
• Patients with a history of Crohn's disease i\* Patients with serious systematic diseases such as congestive heart failure, renal failure or severe liver disease.
• Any blood disorder identified by haematocrit \<30% or \>55%
• History of hepatitis B, hepatitis C, or HIV
• Subject has had prior abdominal surgery of the gastrointestinal tract other than uncomplicated procedures that would be unlikely to lead to bowel obstruction based on the clinical judgment of the investigator
• Female subjects who are pregnant, planning on becoming pregnant or nursing
• Any disorder, which in the investigator's opinion might jeopardise subject's safety or compliance with the protocol.
• Coagulation disorder, wound healing and bleeding disorder or taking anticoagulant medication
• The presence of any other active implanted device, such as cardiac pacemaker or other implanted electro medical devices.
• The presence of any other wireless sensor or transmitter located in abdomen (excluding compatible device also for pressure sensing and other location is acceptable)

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead
• Dotspace Inc.: collaborator

Study Sites (1)

Dong-Ru Ho

Chiayi City, 60061, Taiwan

RECRUITING

Related Publications (2)

• Liao CH, Cheng CT, Chen CC, Wang YH, Chiu HT, Peng CC, Jow UM, Lai YL, Chen YC, Ho DR. Systematic Review of Diagnostic Sensors for Intra-Abdominal Pressure Monitoring. Sensors (Basel). 2021 Jul 15;21(14):4824. doi: 10.3390/s21144824.

  PMID: 34300564 BACKGROUND

• Liao CH, Cheng CT, Chen CC, Jow UM, Chen CH, Lai YL, Chen YC, Ho DR. An Ingestible Electronics for Continuous and Real-Time Intraabdominal Pressure Monitoring. J Pers Med. 2020 Dec 24;11(1):12. doi: 10.3390/jpm11010012.

  PMID: 33374271 RESULT

MeSH Terms

Conditions

Intra-Abdominal Hypertension

Condition Hierarchy (Ancestors)

Compartment Syndromes; Muscular Diseases; Musculoskeletal Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Dong-Ru Ho, MD, PhD

CONTACT

886-975353211; redoxdrh@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Physician

Study Record Dates

• First Submitted: February 20, 2024
• First Posted: March 27, 2024
• Study Start: February 18, 2024
• Primary Completion: July 16, 2024
• Study Completion: September 20, 2025
• Last Updated: March 27, 2024

Record last verified: 2024-03

Locations

TW (1)