Data Collection Study - Recording Electro-physiological Signals From Intact (to be Resected, Pathological) and Ischemic Bowel Tissue During Open Colonic Surgery.

Exero Medical Ltd.1 site in 1 country5 target enrollmentJune 4, 2020

ConditionsOpen/ Laparoscopic/ Robotic Resection of the Colon

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Open/ Laparoscopic/ Robotic Resection of the Colon
Sponsor: Exero Medical Ltd.
Enrollment: 5
Locations: 1
Primary Endpoint: Functionality of signal measurement
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The study is conducted to record continuous electrophysiological signals from intact and ischemic bowel tissue during colonic resection surgery, in order to train the Exero Medical Leak Detection System classification algorithm on detection of ischemic conditions.

Registry

clinicaltrials.gov

Start Date

June 4, 2020

End Date

September 17, 2020

Last Updated

4 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Exero Medical Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Age ≥ 18 years.
•Patient is scheduled for open colonic resection, (right hemicolectomy, left hemicolectomy, sigmoidectomy, anterior resection or subtotal colectomy) surgery.
•Patient has consented to be in the trial and signed informed consent is available before any study related procedures are carried out.

Exclusion Criteria

•Subject has gastroparesis.
•Subject has significant multisystem (autonomic) diseases.
•Subject has a body mass Index greater than 35 kg/m2
•Subject has an autoimmune disorder requiring therapy in the preceding 2 years.
•Subject has significant cardiac arrhythmia or ectopy.
•Obstructing lesion and pre obstruction bowel dilatation
•Subject has an existing implanted electrical stimulator (e.g., pacemaker.
•Subject requires chronic anticoagulant therapy
•Subject is currently enrolled in other potentially confounding research.
•Current alcohol abuse

Outcomes

Primary Outcomes

Functionality of signal measurement

Time Frame: 10 minutes

Baseline data collected from the intended bowel segment to be resected, prior to tissue manipulation, is compared to the data recorded after the ischemia induced by the resection procedure.