Status:
COMPLETED
InTRaoperative Imaging DEvice Based on endogeNous opTical Properties to Evaluate Bowel Oxygenation in Colorectal Resections
Lead Sponsor:
Intuitive Surgical
Conditions:
Left-sided Colorectal Resection : Diverticular Diseases
Left-sided Colorectal Resection : Colonic Neoplasms
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The objective of the study is to assess the safety and technical feasibility of a new imaging system, used during colorectal resection surgery, named Trident in version 1.0, which could be used by the...
Detailed Description
This is a prospective, non-randomized, single center, feasibility trial. All consecutive patients that fulfil the inclusion/exclusion criteria will be informed about the possibility to be included in ...
Eligibility Criteria
Inclusion
- Patient scheduled for a left-sided colorectal resection, irrespective of the surgical approach (open surgery, laparoscopic surgery,) because of:
- Colon cancer OR
- Sigmoid diverticular disease OR
- Rectal cancer
- All genders
- Age \> 18 years old
- Ability to understand the information related to the study protocol
Exclusion
- Pregnancy or breastfeeding
- Contraindications to anaesthesia
- Inability to provide a written informed consent
- Inclusion in a different ongoing clinical trial
- Emergency procedure
- Abdomino-perineal resection
- Hartmann procedure
- Patient is part of vulnerable population (e.g., prisoners, mentally disabled)
Key Trial Info
Start Date :
July 6 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 21 2024
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT05973227
Start Date
July 6 2023
End Date
May 21 2024
Last Update
July 22 2024
Active Locations (1)
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1
CHU Strasbourg
Strasbourg, France