Skip to main content
OpenTrials
Completed

NCT Number: NCT04854473

Collection of Electrophysiological Data During Colon Resection

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Open/ Laparoscopic/ Robotic Resection of the Colon Anastomotic Leak Ischemia Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rabin Medical Center

Petah Tikva, 49100, Israel

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.
  • 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.

Treatment and study plan

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Occurrence of adverse events

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Exero Medical Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Apr 22, 2021
Registry last updated
May 6, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.