Collection of Electrophysiological Data During Colon Resection

NCT04854473 | Completed

• 1 other identifier: CLP-01
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Open/ Laparoscopic/ Robotic Resection of the Colon

Keywords

Exero; anastomotic leak; impedance; ischemia; colon; bowel

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Occurrence of adverse events

  10 minutes

Study Arms (1)

Impedance measurement

EXPERIMENTAL

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

Interventions

Exero Medical Leak Detection System DEVICE

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.

Impedance measurement

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Pregnancy
• Current alcohol abuse
• Subject poses a significant general anesthesia risk
• Subject has any condition that, at the discretion of the investigator, would preclude participation in the trial.

Sponsors & Collaborators

• Exero Medical Ltd.: lead

Study Sites (1)

Rabin Medical Center

Petah Tikva, 49100, Israel

Location

MeSH Terms

Conditions

Anastomotic Leak; Ischemia

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Nir Wasserberg, MD

  Rabin Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2021
• First Posted: April 22, 2021
• Study Start: June 4, 2020
• Primary Completion: September 17, 2020
• Study Completion: September 17, 2020
• Last Updated: May 6, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)