Back to resultsInTRaoperative Imaging DEvice Based on endogeNous opTical Properties to Evaluate Bowel Oxygenation in Colorectal Resections (TRIDENT)
Primary Purpose
Left-sided Colorectal Resection : Diverticular Diseases, Left-sided Colorectal Resection : Colonic Neoplasms, Left-sided Colorectal Resection : Rectal Neoplasms
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
use of the TRIDENT system
Sponsored by
About this trial
This is an interventional device feasibility trial for Left-sided Colorectal Resection : Diverticular Diseases focused on measuring Colorectal surgery, TRIDENT system, Tissue oxygenation
Eligibility Criteria
Inclusion Criteria: 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 Criteria: 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)
Sites / Locations
- CHU StrasbourgRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
interventional arm (use of TRIDENT system)
Arm Description
Outcomes
Primary Outcome Measures
image quality (sharpness, brightness, etc) and surgeon's feedback regarding the ergonomics and safety of Trident System v1.0 during surgery.
descriptive analysis on the quality images by the engineering design team and feedback provided by clinical experts (surgeons) according to ad hoc form evaluating: 1) ergonomics aspects; 2) workflow; 3) risks of breaching sterility; 4) Speed of image acquisition.
Secondary Outcome Measures
- level of oxygenation (StO2) of the exteriorized colon before resection with the Trident System v1.0 - the level of oxygenation (StO2) provided by the system at the site chosen by the surgeon based on the clinical evaluation.
Measurement of StO2 values at the resection site determined by the surgeon based on his clinical judgment and measurement of StO2 levels over the entire length of the colon exteriorized and visible in the field of view of the Trident System v1.0.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05973227
Brief Title
InTRaoperative Imaging DEvice Based on endogeNous opTical Properties to Evaluate Bowel Oxygenation in Colorectal Resections
Acronym
TRIDENT
Official Title
InTRaoperative Imaging DEvice Based on endogeNous opTical Properties to Evaluate Bowel Oxygenation in Colorectal Resections: Observational First-in-human Pilot Safety Trial -TRIDENT-
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 6, 2023 (Actual)
Primary Completion Date
July 2024 (Anticipated)
Study Completion Date
July 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Intuitive Surgical
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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 surgeon during colorectal procedures to obtain information on intestinal tissue oxygenation.
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 the present clinical investigation. Only subjects that have signed the study informed consent will be included in the study. The Trident System v1.0 will be used only during approximately 2 to 5 minutes during a precise surgical step, i.e., just before the final resection of the surgical specimen. Patients will be prospectively followed at 30 days post-surgery. Data will be collected prospectively from the medical records.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Left-sided Colorectal Resection : Diverticular Diseases, Left-sided Colorectal Resection : Colonic Neoplasms, Left-sided Colorectal Resection : Rectal Neoplasms
Keywords
Colorectal surgery, TRIDENT system, Tissue oxygenation
7. Study Design
Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
interventional arm (use of TRIDENT system)
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
use of the TRIDENT system
Intervention Description
usage of Trident System v1.0, just before the final resection, to obtain some images of the tissue oxygenation.
Primary Outcome Measure Information:
Title
image quality (sharpness, brightness, etc) and surgeon's feedback regarding the ergonomics and safety of Trident System v1.0 during surgery.
Description
descriptive analysis on the quality images by the engineering design team and feedback provided by clinical experts (surgeons) according to ad hoc form evaluating: 1) ergonomics aspects; 2) workflow; 3) risks of breaching sterility; 4) Speed of image acquisition.
Time Frame
30 days FU
Secondary Outcome Measure Information:
Title
- level of oxygenation (StO2) of the exteriorized colon before resection with the Trident System v1.0 - the level of oxygenation (StO2) provided by the system at the site chosen by the surgeon based on the clinical evaluation.
Description
Measurement of StO2 values at the resection site determined by the surgeon based on his clinical judgment and measurement of StO2 levels over the entire length of the colon exteriorized and visible in the field of view of the Trident System v1.0.
Time Frame
surgery day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marie Allouis
Phone
+33 786 480 495
Email
EU Clinical Affairs <DL-Department-ClinicalAffairs-EMEA@intusurg.com>
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michele Diana, MD, PhD
Organizational Affiliation
CHU Strasbourg
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Strasbourg
City
Strasbourg
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michele Diana, MD, PhD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
InTRaoperative Imaging DEvice Based on endogeNous opTical Properties to Evaluate Bowel Oxygenation in Colorectal Resections
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