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New device could help colon cancer patients avoid a stoma bag

NCT ID NCT07116668

Disease control Sponsor: SafeHeal Inc Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only This study
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests a temporary device called Colovac that is placed inside the bowel after colon cancer surgery to protect the surgical connection. The goal is to see if it can help patients avoid needing a temporary stoma bag. About 108 adults with colon cancer will take part, and the device is removed after about 10 days.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Colovac Anastomosis Protection Device (a temporary tube placed inside the bowel to protect the surgical connection)
What this could lead to
If successful, this device could help many colon cancer patients avoid a temporary stoma bag after surgery, improving recovery and quality of life.
What could go wrong
This is a relatively small, early-stage study without a comparison group, so results may not apply to all patients. The device may fail to prevent leaks or cause complications.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 108 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2026

Expected to finish

Jul 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

22 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: A subject meeting all of the following criteria will be considered for participation in the study: 1. Adult patients (22 years of age or older) 2. Eligible to undergo open or minimally invasive sphincter-sparing low anterior resection with planned diverting loop ileostomy for malignancy. 3. Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2 4. Willingness to comply with protocol-specific treatment and study visits and to sign a written Informed Consent Form Exclusion Criteria: * Preoperative: 1. Active colitis 2. Known allergy to nickel or other components of the Colovac system 3. Pregnant or nursing female subject 4. Concomitant major surgical procedure in combination with Colorectal resection (i.e., hepatectomy) 5. Any serious or uncontrolled medical disorder that, in the opinion of the investigator, may increase the risk associated with study participation, impair the ability of the participant to undergo protocol-described procedures or interfere with the interpretation of study results including, but not limited to: 1. Stage IV colorectal cancer unless curative intent R0 resection is planned AND there is no associated peritoneal disease 2. Immunodeficiency (CD4+ count \< 500 CU MM) 3. Systemic and ongoing steroid therapy within the past 6 months 4. Systemic infection at the time of surgery or requiring systemic antimicrobial therapy up to 1 week before surgery 5. Major surgical or interventional procedures within 30 days prior to this study or planned surgical or interventional procedures within 30 days of entry into this study 6. Diagnosis of bowel obstruction, bowel strangulation, peritonitis, bowel perforation, intraabdominal infection, ischemic bowel, or carcinomatosis 7. Fecal incontinence, involvement of sphincter by the neoplastic disease or evidence of extensive local disease in the pelvis seen on pre-operative imaging 8. Severe malnutrition defined as 10% weight loss within 3 months prior to enrollment. 6. The subject is currently participating in another investigational drug or device study that may confound the results of SAFE-3CV. Prior approval from SafeHeal Medical Monitor must be obtained prior to enrollment in SAFE-3CV. Intraoperatively: 7. Occurrence of any of the following during the colorectal surgery: 1. Blood loss (\>750 cc) 2. Blood transfusion 3. Any new sign of bowel ischemia 4. Positive air leak test 5. Inadequate bowel preparation 6. Anastomosis location greater than 10 cm from the anal verge 7. Any other surgical complications or intra-operative risks that may place the patient at greater risk from study procedures

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Conditions

The condition(s) this trial relates to.

colorectal cancer colorectal neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Colorectal cancer Stoma ileostomy

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    18 sites in 4 countries. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Bordeaux Colorectal Institute

    Bourdeaux, New Aquitaine, 33000, France

  • Boston Medical Center

    Boston, Massachusetts, 02118, United States

  • Cedars-Sinai Medical Center

    Los Angeles, California, 90048, United States

  • Chu du Rouen

    Rouen, Normandy, 76031, France

  • Geisinger Medical Center

    Danville, Pennsylvania, 17822, United States

  • Hopital Saint-Antoine

    Paris, Île-de-France Region, 75012, France

  • Humanitas Research Hospital

    Rozzano, Lombardi, 20089, Italy

  • Keck Medicine of USC

    Los Angeles, California, 90033, United States

  • Lankenau Medical Center

    Wynnewood, Pennsylvania, 19096, United States

  • Lenox Hill Hospital

    New York, New York, 10075, United States

  • Maimonides Medical Center

    Brooklyn, New York, 11219, United States

  • Mount Sinai Hospital

    New York, New York, 10029, United States

  • Novant Health

    Winston-Salem, North Carolina, 27103, United States

  • Tampa General Hospital

    Tampa, Florida, 33606, United States

  • UZ Leuven

    Leuven, Flemish Brabant, 3000, Belgium

  • UZA

    Edegem, Antwerp, 2650, Belgium

  • University of Massachusetts

    Worcester, Massachusetts, 01605, United States

  • University of Miami

    Miami, Florida, 33146, United States

More trials for these conditions

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