A Wearable Biosensor Patch for Non-Invasive Monitoring for Patients Undergoing Abdominal or Chest Surgery

NCT07612085 | Not Yet Recruiting DMC

• 3 other identifiers: 25132NCI-2026-03601P30CA033572
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This clinical trial tests the feasibility and safety of a wearable biosensor patch for non-invasive monitoring for patients undergoing abdominal or chest surgery. Wearable biosensor patches have been developed by researchers to provide a non-invasive way to monitor substances that are normally checked using blood tests. This may reduce the need for frequent blood draws. The patches use gentle electrical stimulation to produce sweat and tiny built-in sensors to measure substances such as glucose, creatinine, and markers of inflammation, as well as oxygen and carbon dioxide levels. The wearable biosensor patch may be a feasible and safe way to monitor patients undergoing abdominal or chest surgery.

Conditions

Hematopoietic and Lymphatic System Neoplasm; Malignant Solid Neoplasm

Outcome Measures

Primary Outcomes (1)

• Proportion of successful sweat collections (feasibility)

  A successful collection will be defined by patch application with data successfully recorded and sent to the database. Examples of failed collections include, but are not limited to, a patch falling off before data collection can occur or a patch failing to collect and send data to the database. The number of successful collections will be reported as a proportion of the total number of attempted applications. All analyses will be descriptive. Unless otherwise specified, continuous variables will be summarized with mean, standard deviation, median, interquartile range, minimum, and maximum; categorical variables with counts and percentages. Given the small sample, two-sided 95 percent exact (Clopper-Pearson) confidence intervals will be provided for proportions. In addition to the overall success rate, the success rates for each type of patch (intraoperative and postoperative) will be described. All causes of failure (including unknown causes) will be reported.

  Up to 1 year

Secondary Outcomes (3)

• Acceptability of the intervention

  Up to 1 year

• Incidence of treatment related adverse events related to biosensor use

  Up to 1 year

• Processes and resources needed to deploy the wearable biosensor patches postoperatively

  Up to 1 year

Study Arms (1)

Diagnostic (wearable biosensor patch)

EXPERIMENTAL

Patients have the wearable biosensor patch placed on the upper back or shoulder during surgery and wear it for the duration of the surgery to monitor oxygen and carbon monoxide levels. Starting the day after surgery, patients wear a biosensor patch on their wrist along with a sweat collecting chamber for 2-4 hours, up to twice daily, for up to 3 days post-operatively.

Procedure: Biospecimen Collection; Other: Electronic Health Record Review; Other: Interview; Other: Survey Administration; Device: Wearable Biosensor Patch

Interventions

Biospecimen Collection PROCEDURE

Undergo sweat sample collection

Also known as: Biological Sample Collection, Biospecimen Collected, Sample Collection, Specimen Collection

Diagnostic (wearable biosensor patch)

Electronic Health Record Review OTHER

Ancillary studies

Diagnostic (wearable biosensor patch)

Interview OTHER

Ancillary studies

Diagnostic (wearable biosensor patch)

Survey Administration OTHER

Ancillary studies

Diagnostic (wearable biosensor patch)

Wearable Biosensor Patch DEVICE

Wear biosensor patch

Diagnostic (wearable biosensor patch)

Eligibility Criteria

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

You may qualify if:

• Age ≥ 18 years
• Scheduled to have an elective abdominal or thoracic operation with anticipated post-operative hospitalization ≥ 3 days
• Willingness to provide sweat samples, complete surveys, and permit review of medical records for research use
• Ability to consent to the study procedures

You may not qualify if:

• Carbachol or pilocarpine allergy
• Adhesive/tape allergy
• Damaged or irritated skin on one or both wrists that prohibits placement of the biosensor and sweat collecting devices
• Pregnant women
• Children less than 18 years of age

Sponsors & Collaborators

• City of Hope Medical Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

City of Hope Medical Center

Duarte, California, 91010, United States

Location

MeSH Terms

Interventions

Specimen Handling; Interviews as Topic

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Data Collection; Epidemiologic Methods; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Kelly Mahuron

  City of Hope Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: May 21, 2026
• First Posted: May 28, 2026
• Study Start (Estimated): September 2, 2026
• Primary Completion (Estimated): April 15, 2027
• Study Completion (Estimated): April 15, 2027
• Last Updated: May 28, 2026

Record last verified: 2026-05

Locations

US (1)