NCT04854473

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.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: Exero Medical Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2020-06-04
• Primary completion: 2020-09-17
• Completion: 2020-09-17
• First posted: 2021-04-22
• Last updated: 2021-05-06

Locations

1 site across 1 country: Israel