Collection of Electrophysiological Data During Colon Resection

Not Applicable

Completed

• Conditions: Open/ Laparoscopic/ Robotic Resection of the Colon
• Interventions: Device: Exero Medical Leak Detection System

• Registration Number: NCT04854473
• Lead Sponsor: Exero Medical Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-06-04
• Primary Completion: 2020-09-17
• Study Completion: 2020-09-17
• Study First Submitted: 2021-04-18
• Study First Submitted QC: 2021-04-18
• Study First Posted: 2021-04-22
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-02
• Last Update Posted: 2021-05-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5

Inclusion Criteria

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

Exclusion Criteria

1. Subject has gastroparesis.
2. Subject has significant multisystem (autonomic) diseases.
3. Subject has a body mass Index greater than 35 kg/m2
4. Subject has an autoimmune disorder requiring therapy in the preceding 2 years.
5. Subject has significant cardiac arrhythmia or ectopy.
6. Obstructing lesion and pre obstruction bowel dilatation
7. Subject has an existing implanted electrical stimulator (e.g., pacemaker.
8. Subject requires chronic anticoagulant therapy
9. Subject is currently enrolled in other potentially confounding research.
10. Pregnancy
11. Current alcohol abuse
12. Subject poses a significant general anesthesia risk
13. Subject has any condition that, at the discretion of the investigator, would preclude participation in the trial.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Impedance measurement	Exero Medical Leak Detection System	Subjects with Exero's Smart Drain Device Attached This arm contains subjects which will have Exero's leak detection Device used: Exero Smart Drain is placed on their large bowel during colonic resection surgery (either open, laparoscopic or robotic). The study aims to demonstrate that the parameters measured by the device in in-vivo, non-disrupted tissue are different than parameters measured in ischemic tissue. Once this data is collected a detection algorithm can be trained. This procedure will add no more than 20 minutes to the existing procedure that is performed per hospital standard overall and will enable collection of control vs. ischemia induced clinical data, essential to developing the detection algorithms.

Primary Outcome Measures

Name	Time	Method
Functionality of signal measurement	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.

Secondary Outcome Measures

Name	Time	Method
Occurrence of adverse events	10 minutes	Adverse events both expected and unexpected, related or unrelated to study device or procedure, graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.03

Trial Locations

Locations (1)

Rabin Medical Center; 🇮🇱 Petah Tiqwa, Israel