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

Pilot Study on the Clinical Application of a Wearable Biosensor Patch for Non-Invasive Measurement of Biochemical and Blood Gas Analytes

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Malignant Solid Neoplasm; Hematopoietic and Lymphatic System Neoplasm
• Intervention / Treatment: Other: Survey Administration; Other: Interview; Other: Electronic Health Record Review; Procedure: Biospecimen Collection; Device: Wearable Biosensor Patch

Detailed Description

PRIMARY OBJECTIVE:

I. To evaluate the feasibility of data collection using wearable postoperative biosensor patch.

SECONDARY OBJECTIVES:

I. To evaluate patient acceptability with using the wearable biosensor patch. II. To evaluate the safety of the wearable biosensor patch. III. To assess processes and resources needed to deploy the wearable biosensor patches postoperatively.

EXPLORATORY OBJECTIVES:

I. To explore the consistency of sweat analyte concentrations obtained using the wearable biosensor patch and a standard sweat collector.

II. To explore the accuracy of sweat-derived analyte concentrations relative to peripheral blood measurements (gold standard).

III. To explore the feasibility of intraoperative blood gas monitoring using a transcutaneous biosensor patch measuring oxygen (O₂) and carbon dioxide (CO₂).

IV. To explore the accuracy of O₂ and CO₂ concentrations obtained from the transcutaneous biosensor patch relative to paired intraoperative blood gas measurements (gold standard).

OUTLINE:

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 dioxide 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.

After completion of study intervention, patients may be followed up for up to 1 year.

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Duarte, California, United States, 91010
      • City of Hope Medical Center
      • Contact: Kelly Mahuron; Phone Number: 89200 626-256-4673; Email: kmahuron@coh.org
      • Principal Investigator: Kelly Mahuron

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Diagnostic (wearable biosensor patch); 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.

Other: Survey Administration; Ancillary studies; Other: Interview; Ancillary studies; Other: Electronic Health Record Review; Ancillary studies; Procedure: Biospecimen Collection; Undergo sweat sample collection; Other Names: Biological Sample Collection; Biospecimen Collected; Specimen Collection; Sample Collection; Device: Wearable Biosensor Patch; Wear biosensor patch

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acceptability of the intervention	Assessed using Acceptability of Intervention Measure (AIM) scores and qualitative data analysis of patient exit interviews. Scores will be summarized descriptively. Exit interviews will be conducted to explore subjective experience with the biosensor patch. Topics will include comfort/discomfort while wearing the patch, comfort/discomfort during application and removal, and open-ended feedback. 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.	Up to 1 year
Incidence of treatment related adverse events related to biosensor use	Safety will be evaluated based on the incidence of treatment-emergent adverse events deemed definitely, probably, or possibly related to the biosensor device. Adverse events will be graded using the Common Terminology Criteria for Adverse Events version 5.0. 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.	Up to 1 year
Processes and resources needed to deploy the wearable biosensor patches postoperatively	Processes and resources needed to deploy the biosensor patches will be assessed through one focus group. Topics will include: approximate time to setting up the patch for patients and applying them, barriers and facilitators in deploying the patches, and open-ended feedback. 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.	Up to 1 year

Collaborators and Investigators

• Sponsor: City of Hope Medical Center
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Kelly Mahuron, City of Hope Medical Center

Study record dates

Study Major Dates

• Study Start (Estimated): September 2, 2026
• Primary Completion (Estimated): April 15, 2027
• Study Completion (Estimated): April 15, 2027

Study Registration Dates

• First Submitted: May 21, 2026
• First Submitted That Met QC Criteria: May 21, 2026
• First Posted (Actual): May 28, 2026

Study Record Updates

• Last Update Posted (Actual): May 28, 2026
• Last Update Submitted That Met QC Criteria: May 21, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Health Care Quality, Access, and Evaluation; Investigative Techniques; Epidemiologic Methods; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Data Collection; Health Care Evaluation Mechanisms; Quality of Health Care; Public Health; Environment and Public Health; Interviews as Topic; Specimen Handling
• Other Study ID Numbers: 25132 (Other Identifier: City of Hope Medical Center); P30CA033572 (U.S. NIH Grant/Contract); NCI-2026-03601 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No