Status:
COMPLETED
Collection of Electrophysiological Data During Colon Resection
Lead Sponsor:
Exero Medical Ltd.
Conditions:
Open/ Laparoscopic/ Robotic Resection of the Colon
Eligibility:
All Genders
18+ years
Phase:
NA
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 Syst...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 4 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 17 2020
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT04854473
Start Date
June 4 2020
End Date
September 17 2020
Last Update
May 6 2021
Active Locations (1)
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1
Rabin Medical Center
Petah Tikva, Israel, 49100