Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hematopoietic and Lymphatic System Neoplasm | Hematopoietic and Lymphatic System Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Malignant Solid Neoplasm | Malignant Solid Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Biospecimen Collection | Procedure | — | UNRESOLVED |
| Electronic Health Record Review | Other | — | UNRESOLVED |
| Interview | Other | — | UNRESOLVED |
| Survey Administration | Other | — | UNRESOLVED |
| Wearable Biosensor Patch | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Diagnostic (wearable biosensor patch)
- description
- 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.
- interventionNames
- Procedure: Biospecimen Collection
- Other: Electronic Health Record Review
- Other: Interview
- Other: Survey Administration
- Device: Wearable Biosensor Patch
Primary outcomes (1)
- measure
- Proportion of successful sweat collections (feasibility)
- timeFrame
- Up to 1 year
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available