Colorectal Cancer Trial, Recruiting NCT04184973 Sponsor: Colospan Ltd. Condition: Colorectal Cancer
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Colorectal Cancer Trial, Recruiting

NCT04184973
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 willing to attend and complete all follow-up appointments required by the study.
  • People who are between 22 and 65 years old at the screening visit, or between 66 and 70 years old with no more than one heart, metabolic, or lung condition for which medication has been prescribed.
  • People who have been diagnosed with colorectal cancer.
  • People who are scheduled for a planned (non-emergency) bowel surgery — either open, keyhole, or robotic — that involves removal of tissue around the rectum and requires joining two sections of bowel together, with the join located no more than 10 cm from the opening of the back passage.
  • People whose surgical plan already includes the creation of a temporary protective stoma (a surgical opening in the abdomen to divert waste) as part of their standard care.
  • People who are scheduled to have bowel preparation (a process to clear the bowel before surgery).
  • People who have been fully informed about the study, agree to its requirements, and have signed a written consent form approved by an ethics committee.

Who may not be able to join:

  • People who have a local or widespread infection in their body at the time of the procedure (such as an infection inside the abdomen).
  • People who have had a major surgery or procedure within the 45 days before the study, or who have another major surgery or procedure planned within 6 months of joining (not counting port placement for chemotherapy or ureteral stent insertion).
  • People whose overall physical health is rated as too high-risk under a standard medical classification system known as ASA — specifically, those rated above category 3 (confirm with trial site).
  • People whose blood albumin (a protein that reflects nutritional status) is below 30 g per litre.
  • People who have been diagnosed with a blocked bowel, bowel strangulation, abdominal infection, bowel perforation, bowel tissue death, cancer spread throughout the abdomen, or severe widespread inflammatory bowel disease.
  • People who have a condition affecting blood clotting, low platelet counts, or a weakened immune system.
  • People with a body mass index (BMI) of 40 or higher.
  • People who are having any additional surgical procedure at the same time, other than a stoma creation or the separation of internal scar tissue (adhesiolysis).
  • People who are currently taking part in another clinical study of an investigational drug or device, unless the trial sponsor has given prior approval.
  • People who have been regularly taking steroid or other systemic medications in the past 6 months.
  • People who are currently taking antimetabolite medications or antiplatelet medications (drugs that affect cell growth or blood clotting).
  • People who already have problems with the muscle that controls the back passage (sphincter).
  • People who have extensive disease in the pelvic area or who have previously had a bowel join (anastomosis) performed in the pelvis.
  • People who have a large number of pouches (diverticulosis) in the lower part of the large bowel, as seen on a pre-operative CT scan.
  • People who have any other condition that, in the opinion of the study doctor, could affect their safety or the reliability of the study results.
  • People who are pregnant or breastfeeding. Women who could become pregnant must have a negative pregnancy test within 7 days before the surgical procedure.

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 20 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

Phone: +972-9-7672518

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
Colospan Ltd.
Registry
ClinicalTrials.gov
Start date
23 June 2020
Est. completion
31 December 2026

Where this trial is recruiting

🇩🇪 Germany 🇮🇱 Israel 🇮🇹 Italy 🇨🇭 Switzerland 🇺🇸 United States

Primary endpoints

Change in Stoma creation rate; Incidence of complications

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: 20 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