Collection of Electrophysiological Data During Colon Resection

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

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.

Study Overview

• Status: Completed
• Conditions: Open/ Laparoscopic/ Robotic Resection of the Colon
• Intervention / Treatment: Device: Exero Medical Leak Detection System

• Study Type: Interventional
• Enrollment (Actual): 5
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Petah Tiqwa, Israel, 49100
    • Rabin Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• 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: Impedance measurement; 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.

Device: Exero Medical Leak Detection System; the Exero Leak Detection System components used in this study are: Smart drain - a surgical drain with added sensing electrodes; Transceiver /Recording Unit (TRU) - a wearable placed outside the body on intact skin and is connected to the implanted electrodes. The unit also acts as a wireless connection to the Monitoring Subsystem.; Monitoring Subsystem - a tablet or a computer connected wirelessly to the transceiver providing logging, applying analysis algorithms on the logged signals and providing indication/alerts to the medical staff derived from the signals recorded by the electrodes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functionality of signal measurement	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.	10 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Occurrence of adverse events	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	10 minutes

Collaborators and Investigators

• Sponsor: Exero Medical Ltd.
• Investigators: Principal Investigator: Nir Wasserberg, MD, Rabin Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): June 4, 2020
• Primary Completion (Actual): September 17, 2020
• Study Completion (Actual): September 17, 2020

Study Registration Dates

• First Submitted: April 18, 2021
• First Submitted That Met QC Criteria: April 18, 2021
• First Posted (Actual): April 22, 2021

Study Record Updates

• Last Update Posted (Actual): May 6, 2021
• Last Update Submitted That Met QC Criteria: May 2, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: anastomotic leak; ischemia; colon; bowel; impedance; Exero
• Other Study ID Numbers: CLP-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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