A Wearable Biosensor Patch for Non-Invasive Monitoring for Patients Undergoing Abdominal or Chest Surgery
21 maj 2026 uppdaterad av: City of Hope Medical Center
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.
Studieöversikt
Status
Har inte rekryterat ännu
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Beräknad)
20
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
California
-
Duarte, California, Förenta staterna, 91010
- City of Hope Medical Center
-
Kontakt:
- Kelly Mahuron
- Telefonnummer: 89200 626-256-4673
- E-post: kmahuron@coh.org
-
Huvudutredare:
- Kelly Mahuron
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Beskrivning
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
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Diagnostisk
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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.
|
Sidostudier
Sidostudier
Sidostudier
Undergo sweat sample collection
Andra namn:
Wear biosensor patch
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Proportion of successful sweat collections (feasibility)
Tidsram: Up to 1 year
|
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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Acceptability of the intervention
Tidsram: Up to 1 year
|
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
Tidsram: Up to 1 year
|
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
Tidsram: Up to 1 year
|
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
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Kelly Mahuron, City of Hope Medical Center
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Beräknad)
2 september 2026
Primärt slutförande (Beräknad)
15 april 2027
Avslutad studie (Beräknad)
15 april 2027
Studieregistreringsdatum
Först inskickad
21 maj 2026
Först inskickad som uppfyllde QC-kriterierna
21 maj 2026
Första postat (Faktisk)
28 maj 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
28 maj 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
21 maj 2026
Senast verifierad
1 maj 2026
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 25132 (Annan identifierare: City of Hope Medical Center)
- P30CA033572 (U.S.S. NIH-anslag/kontrakt)
- NCI-2026-03601 (Registeridentifierare: CTRP (Clinical Trial Reporting Program))
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
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