Left-sided Colorectal Resection : Diverticular DiseasesTRIDENTNCT05973227
InTRaoperative Imaging DEvice Based on endogeNous opTical Properties to Evaluate Bowel Oxygenation in Colorectal Resections
A study testing use of the TRIDENT system in people with Left-sided Colorectal Resection : Diverticular Diseases and Left-sided Colorectal Resection : Colonic Neoplasms, run by Intuitive Surgical at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Left-sided Colorectal Resection : Diverticular Diseases, Left-sided Colorectal Resection : Colonic Neoplasms, Left-sided Colorectal Resection : Rectal Neoplasms
- What is being tested?
- use of the TRIDENT system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteFrance
- Study dates
- 6 Jul 2023to 21 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 11Show fewer
- Ability to understand the information related to the study protocol
- Emergency procedure
- Abdomino-perineal resection
- Hartmann procedure
- Patient is part of vulnerable population (e.g., prisoners, mentally disabled)
Who cannot join
- Pregnancy or breastfeeding
- Contraindications to anaesthesia
- Inability to provide a written informed consent
Trial locations and contacts
1 site in 1 country.
About this study
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-
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.
Read 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 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.
- Conditions
- Left-sided Colorectal Resection : Diverticular Diseases, Left-sided Colorectal Resection : Colonic Neoplasms, Left-sided Colorectal Resection : Rectal Neoplasms
- Being tested
- use of the TRIDENT system
- Keywords
- Colorectal surgery, TRIDENT system, Tissue oxygenation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
use of the TRIDENT systemDevice
usage of Trident System v1.0, just before the final resection, to obtain some images of the tissue oxygenation.
| Study group | Role | What they receive |
|---|---|---|
| interventional arm (use of TRIDENT system) | Experimental | Not described Receives: Device: use of the TRIDENT system |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 days FU
Secondary outcomes (1)
- 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.
Measured: surgery day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2023
- Study start6 Jul 2023
- Primary completion21 May 2024
- Study completion21 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Left-sided Colorectal Resection : Diverticular DiseasesStudies of the same condition, open and under way.
- More trials run by Intuitive SurgicalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Intuitive Surgical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Didier Mutter, MD, PhD, Principal investigator, CHU Strasbourg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05973227
- Sponsor's protocol ID
- 1094572-01C
- Acronym
- TRIDENT
- Status last verified
- Jul 2024
- First submitted
- 26 Jul 2023
- Last updated
- 22 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lapergola A, Baratelli L, Shein GS, Philouze G, Kpekou S, Pardo A, Triponez F, Mutter D, Gioux S, Diana M. TRIDENT: inTRaoperative Imaging DEvice based on endogeNous opTical properties to evaluate bowel oxygenation in left-sided colorectal resections. Observational first-in-human pilot safety trial. Surg Endosc. 2026 Oct 12. doi: 10.1007/s00464-026-13429-6. Online ahead of print.
PubMed 42864469
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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-
- ClinicalTrials.gov ID
- NCT05973227
- Acronym / sponsor ID
- TRIDENT / 1094572-01C
- Conditions
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Intuitive SurgicalIndustry (pharma, biotech, devices)
- Study start
- 6 Jul 2023 (actual)
- Primary completion
- 21 May 2024 (actual)
- Study completion
- 21 May 2024 (actual)
- First posted
- 2 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| interventional arm (use of TRIDENT system) | Experimental | Device: use of the TRIDENT system |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Patient scheduled for a left-sided colorectal resection, irrespective of the surgical approach (open surgery, laparoscopic surgery,) because of:
- All genders
- Age > 18 years old
- Ability to understand the information related to the study protocol
- Emergency procedure
Key exclusion criteria (3 listed)
- Pregnancy or breastfeeding
- Contraindications to anaesthesia
- Inability to provide a written informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| use of the TRIDENT systemusage of Trident System v1.0, just before the final resection, to obtain some images of the tissue oxygenation. | Device | interventional arm (use of TRIDENT system) |
Primary outcome
image quality (sharpness, brightness, etc) and surgeon's feedback regarding the ergonomics and safety of Trident System v1.0 during surgery.
Time frame: 30 days FU
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.
1 secondary outcome
- 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.
Time frame: surgery day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2024.
- Derived from this study: PubMed 42864469Lapergola A, Baratelli L, Shein GS, Philouze G, Kpekou S, Pardo A, Triponez F, Mutter D, Gioux S, Diana M. TRIDENT: inTRaoperative Imaging DEvice based on endogeNous opTical properties to evaluate bowel oxygenation in left-sided colorectal resections. Observational first-in-human pilot safety trial. Surg Endosc. 2026 Oct 12. doi: 10.1007/s00464-026-13429-6. Online ahead of print.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Didier Mutter, MD, PhD principal investigator
CHU Strasbourg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing use of the TRIDENT system in people with Left-sided Colorectal Resection : Diverticular Diseases and Left-sided Colorectal Resection : Colonic Neoplasms, run by Intuitive Surgical at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
image quality (sharpness, brightness, etc) and surgeon's feedback regarding the ergonomics and safety of Trident System v1.0 during surgery. (time frame: 30 days FU). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05973227, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2024.