An interventional study of use of the TRIDENT system in Left-sided Colorectal Resection : Diverticular Diseases, Left-sided Colorectal Resection : Colonic Neoplasms and Left-sided Colorectal Resection : Rectal Neoplasms, sponsored by Intuitive Surgical. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-07-22.
Sponsored by Intuitive Surgical · Not applicable, Interventional, and Device feasibility
Among 213 studies in Colonic Neoplasms with a site in France — 49 open to participants now, 66 under way, 13 of them phase 3. Colonic Neoplasms · France.
Among the 213 studies in Colonic Neoplasms with a site in France, this one is the 141st largest by enrollment of the 143 interventional ones, is one of 14 that started in 2023, is one of 43 with no phase, and was the 180th registered.
2,457 studies on the registry are indexed under Colonic Neoplasms; 458 are open to participants now.
This study's enrollment of 10 is below the median of 75 across 1,711 interventional studies indexed under Colonic Neoplasms.
Browse Colonic Neoplasms studies →49 of the 213 studies in Colonic Neoplasms with a site in France are open now, in 12 countries. Each count lists the studies.
Of the 326 Colonic Neoplasms studies recruiting now, 203 (62%) set no upper age limit and 71 (22%) stop at 75 or younger; 19 take children under 18; 34 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →213 studies; the count open now beside each. This study's row is marked.
First in 1990; this study’s year is marked. 14 started in 2023.
Median enrollment 186 across the 143 interventional studies, 220 across the 55 observational. Of the 106 that completed or were terminated, 20 (19%) have results posted.
45 of 213 have an industry lead sponsor. The 10 most frequent:
Intuitive Surgical is the lead sponsor of 62 studies on the registry; 6 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 1 (14%) have results posted.
Intuitive Surgical has 4 studies filed under Colonic Neoplasms — fewer than ten, so there is no comparison to draw.
10 of the studies in Colonic Neoplasms with a site in France that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07000474University Hospital, BrestMultiparametric Characterization of Colorectal Cancers (METRAD) | 2026-12-31 |
| NCT05433142Xencor, Inc.Study of XmAb®819 in Subjects With Advanced Clear Cell Renal Cell Carcinoma | 2027-02 |
| NCT05577143University Hospital, LilleBlood Screening for Adult Colorectal Cancer | 2027-03 |
| NCT05462717Revolution Medicines, Inc.Dose Escalation and Dose Expansion Study of RMC-6291 Monotherapy in Subjects With Advanced KRASG12C Mutant Solid Tumors | 2027-03-31 |
| NCT06287814University Hospital, MontpellierFrench Assessment of MRD by Liquid Biopsies in Stage III CRC Patients (FRENCH.MRD.CRC) | 2027-04-11 |
Among the 213 studies in Colonic Neoplasms with a site in France, from their registry updates:
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.
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.
Inclusion Criteria:
Patient scheduled for a left-sided colorectal resection, irrespective of the surgical approach (open surgery, laparoscopic surgery,) because of:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Device: use of the TRIDENT system
usage of Trident System v1.0, just before the final resection, to obtain some images of the tissue oxygenation.
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.
Time frame: 30 days FU
- 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.
Time frame: surgery day
Plan to share: No
No publications or documents are linked to this record.
Ran from Jul 2023 to primary completion in May 2024, 10 months.
Of 404 interventional studies with no phase under Colonic Neoplasms, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 51. This study's 10 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.
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