Collection of Electrophysiological Data During Colon Resection

NCT ID: NCT04854473

Last Updated: 2021-05-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-04
• Study Completion Date: 2020-09-17

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DEVICE_FEASIBILITY
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Exero Medical Leak Detection System

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Exero Medical Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nir Wasserberg, MD

Role: PRINCIPAL_INVESTIGATOR

Rabin Medical Center

Locations

Rabin Medical Center

Petah Tikva, , Israel

Countries

Israel

Other Identifiers

CLP-01

Identifier Type: -

Identifier Source: org_study_id