NCT05973227Completed
InTRaoperative Imaging DEvice Based on endogeNous opTical Properties to Evaluate Bowel Oxygenation in Colorectal Resections
InTRaoperative Imaging DEvice Based on endogeNous opTical Properties to Evaluate Bowel Oxygenation in Colorectal Resections: Observational First-in-human Pilot Safety Trial -TRIDENT-
Source: ClinicalTrials.gov · Last updated 22 Jul 2024
Brief summary (registry, in English)
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 surgeon during colorectal procedures to obtain information on intestinal tissue oxygenation.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 10 (actual)
- First submitted
- 26 Jul 2023
- Start date
- 6 Jul 2023
- Primary completion date
- 21 May 2024
- Lead sponsor
- Intuitive Surgical
- Diseases
- Colorectal cancer
- NCT number
- NCT05973227
What you commit to
- Study type: Interventional
- Participants enrolled: 10
- From 6 Jul 2023 to the primary completion date, 21 May 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Abdomino-perineal resection
Other
- Pregnancy or breastfeeding
- Contraindications to anaesthesia
- Inability to provide a written informed consent
- Inclusion in a different ongoing clinical trial
- Emergency procedure
- Hartmann procedure
- Patient is part of vulnerable population (e.g., prisoners, mentally disabled)
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| CHU Strasbourg Coordinator of this site? Confirm its status | Strasbourg | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.