Colorectal Cancer Trial, Recruiting NCT07351071 Sponsor: Medtronic - MITG Condition: Colorectal Cancer
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Colorectal Cancer Trial, Recruiting

NCT07351071
Recruiting Not Applicable

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People who are able to understand the study and are willing to sign a consent form agreeing to take part
  • People who are scheduled for a planned (non-emergency) surgical procedure on the left side of the colon or rectum, where the surgeon will reconnect the bowel using a specific stapling device called the Signia™ circular stapler
  • People who are 18 years of age or older at the time they sign the consent form

Who may not be able to join:

  • People who are unable or unwilling to follow the study requirements or attend follow-up appointments
  • People whose overall health is rated as very poor or critically ill using a standard medical scoring system called ASA classification (specifically a score of IV or higher — confirm with trial site)
  • People who are pregnant at the time of the procedure
  • People whose surgery is being done as an emergency rather than a planned procedure
  • People whose surgery is a repeat operation for the same condition that was already operated on before
  • People who have a serious underlying health condition that the study doctor believes makes participation unsuitable, or whose life expectancy is estimated to be less than 6 months
  • People who are currently taking part in, or planning to take part in, another research study involving an experimental drug or medical device that could affect this study's results
  • People who are having more than one section of the colon removed at the same time during the same operation
  • People who have a bleeding disorder, or who are taking blood-thinning medication that has not been stopped or reversed before surgery (note: blood-thinning medication given as a routine part of the surgical process is permitted)
  • People who have received chemotherapy or certain biological treatments within 6 weeks before the date of surgery
  • People who have used corticosteroid medications long-term (more than 3 months within the year before the surgery)
  • People who have been on immune-suppressing medications long-term (more than 3 months within the year before the surgery)
  • People whose surgery involves creating a pouch from the small intestine connected to the anus (called an ileal-anal pouch anastomosis)
  • Cases where the Signia™ circular stapler is not used to complete the bowel reconnection during surgery
  • Cases where the stapling device would need to be used in a way that goes beyond its standard approved instructions

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 26 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Principal Investigator: Katharine Louise Jackson, MD, FACS, MBBS, MA, Duke Raleigh Hospital

Phone: +7635050079

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Not Applicable
Sponsor
Medtronic - MITG
Registry
ClinicalTrials.gov
Start date
30 December 2025
Est. completion
31 December 2026

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Incidence of anastomotic leak

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 26 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov