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Colorectal CancerSAFE2019NCT05180565

Safe Anastomosis Feasibility Study

A study testing Colovac in people with Colorectal Cancer and Anastomosis, run by SafeHeal Inc at 7 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

A clinical trial to assess the efficacy, mechanism of action and safety of the Colovac+ Colorectal Anastomosis Protection Device in providing temporary protection of the anastomosis in subjects undergoing lower anterior resection for colorectal cancer Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Colorectal Cancer, Anastomosis
What is being tested?
Colovac
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
27 participants
Where
7 sitesin 2 countries
Study dates
18 Dec 2019to 31 Mar 2022
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

  • Adult patients (18 years of age or older)
  • Eligible to undergo open or minimally invasive sphincter-sparing low anterior resection with planned diverting loop ileostomy for malignancy, based on multidisciplinary team recommendations.
  • Willingness to comply with Clinical Investigation Plan-specific treatment and study visits and to sign a written Informed Consent Form

Who cannot join

  • Preoperatively :
  • Patient with inflammatory bowel disease
  • Known allergy to nickel or other components of the Colovac+ kit
  • Pregnant or nursing female subject
  • Concomitant major surgical procedure in combination with Colorectal resection (i.e. hepatectomy)
  • 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 Clinical Investigation Plan described procedures or interfere with the interpretation of study results. including, but not limited to:
Show all 25Show fewer
  • COVID-19 positive (active infection) based on test within 72 hours prior to surgery
  • Metastatic disease - unless previously treated with chemotherapy and resection, and the benefit of exposure to the Colovac device is greater than the risk 1
  • Immunodeficiency (CD4+ count < 500 CU MM)
  • Systemic steroid therapy within the past 6 months
  • Systemic infection at the time of surgery or requiring systemic antimicrobial therapy up to 1 week before surgery
  • 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
  • Diagnosis of bowel obstruction, bowel strangulation, peritonitis, bowel perforation, intraabdominal infection, ischemic bowel, carcinomatosis
  • Fecal incontinence, involvement of sphincter by the neoplastic disease or evidence of extensive local disease in the pelvis seen on pre-operative imaging
  • Severe Malnutrition defined as 10% weight loss within 3 months prior to enrollment.
  • The subject is currently participating in another investigational drug or device study
  • Intraoperatively :
  • Anastomosis placement at more than 10cm from anal margin
  • Occurrence of any of the following during the colorectal surgery:
  • Blood loss (>750 cc)
  • Blood transfusion
  • Any new sign of ischemia
  • Positive air leak test - requiring re intervention on the anastomosis
  • Inadequate bowel preparation
  • Other intra-operative risks that preclude the subject from undergoing the procedure with the investigational device

Trial locations and contacts

7 sites in 2 countries.

7 sites in 2 countries

France5 sites

  • CHU Lille

    Lille, 59000

  • ICM Montpellier

    Montpellier, 34090

  • Hôpital Saint Louis

    Paris, 75010

  • Hôpital Saint Antoine Paris

    Paris, 75012

  • CHRU Strasbourg

    Strasbourg, 67000

Other trials in France

Belgium2 sites

  • UZA

    Antwerp, 2610

  • Centre Hospitalier Universitaire St Pierre

    Brussels, 1000

Other trials in Belgium

About this study

Official title: Safe Anastomosis Feasibility Study: a Study to Investigate the Efficacy, Mechanism of Action and Safety of the Colovac+ Colorectal Anastomosis Protection Device

A clinical trial to assess the efficacy, mechanism of action and safety of the Colovac+ Colorectal Anastomosis Protection Device in providing temporary protection of the anastomosis in subjects undergoing lower anterior resection for colorectal cancer

Read the detailed description

A primary diverting stoma is widely used by surgeons in order to bypass the low rectal anastomosis and reduce morbidity associated with anastomotic leaks. Typically, a stoma is created for all high-risk patients which means that many patients are exposed to potentially serious complications associated with the stoma itself without any clinical benefit.

Colovac+ is a local, temporary, minimally invasive bypass device that provides protection of the anastomosis and safely postpones stoma creation for 10 days after surgery. By postponing stoma creation for 10 days, Colovac is designed to avoid stoma creation in all patients except those patients whose anastomoses have not healed by 10 days after surgery, allowing the others to return to normal activity more quickly and safely.

Being tested
Colovac
Keywords
anastomosis
Medical subject headings
Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ColovacDevice

    A removable, temporary intraluminal bypass device designed to safely postpone the creation of a protective stoma until 10 days after surgery for only patients who need it (do not have a healed anastomosis)

Study groups in NCT05180565
Study groupRoleWhat they receive
ColovacExperimentalPatients receive Colovac device during colorectal surgery
Receives: Device: Colovac

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. To measure the incidence of serious adverse events related to using the device

    The primary endpoint will be a measurement of SAEs probably related or causaly related to the use of the investigational device, to the index surgery in this clinical trial.

    Measured: 3 months

Secondary outcomes (11)

  1. To measure the number of participants with evidence of absence of feces between the sheath and the colonic wall before device retrieval

    Rate of patients with evidence of absence of feces between the sheath and the colonic wall before device retrieval at 10 days:

    Measured: 10 days

  2. To measure the rate of ostomy avoidance

    To measure the number of participants where ostomy was avoided

    Measured: 3 months

  3. To evaluate the occurrence of clinical anastomotic leakage

    Rate of clinical leakage, defined as number of clinically manifest insufficiency of the anastomosis leading to a clinical state requiring treatment:

    • Rate of patients with radiological evidence of anastomotic leakage if the patient is clinically symptomatic
    • Prior to retrieval of the Colovac+ Device, a systematic contrast radiographic imaging will be performed using a radio-opaque contrast agent injected trans-anally, in order to check for any potential anastomotic complication.

    Measured: 3 months

  4. To measure on a scale of 1 to 5 rated by the surgeon the ease of device introduction, positioning and endoscopic retrieval

    • Ease of device introduction and positioning will be rated by the surgeon on a scale from 1 to 5 (1 being very easy and 5 being impossible)
    • Ease of endoscopic retrieval of the device will be rated by the endoscopist on a scale from 1 to 5 (1 being very easy and 5 being impossible)

    Measured: 10 days

  5. To evaluate the clinically significant migration rate

    Clinically significant migration is defined as movement of device that allows fecal contents to reach the anastomosis site evidenced by:

    • Migration of entire stent to or below the Sacral Promontory as indicated by fluctuation in the length of the sheath that extends out of the anus and confirmed by radiographicdisplacement; or
    • Expulsion of the device

    Measured: 10 days

  6. To evaluate the integrity above the anchoring site during the device retrieval using endoscopy.

    Mucosal appearance above the anchoring site will be evaluated endoscopically during device retrieval and classified as Normal/Inflamed, Bleeding, Ulcerated, Perforated.

    Measured: 10 days

  7. To evaluate the integrity of the anchoring site during the device retrieval using endoscopy.

    Mucosal appearance at the anchoring site will be evaluated endoscopically during device retrieval and classified as Normal/Inflamed, Bleeding, Ulcerated, Perforated.

    Measured: 10 days

  8. To evaluate the integrity of the anastomosis before the device retrieval using fluoroscopy

    Fluoroscopy with injection of contrast between the colonic wall and the sheath will be performed prior to retrieval of the Colovac+ Device in order to check for anastomotic integrity before device retrieval.

    Outcome is measured with presence/absence of any contrast liquid leak through the anastomosis prior to device retrieval.

    Measured: 10 days

  9. To evaluate the integrity of the anastomosis after the device retrieval using fluoroscopy

    Fluoroscopy with injection of contrast per rectum will be performed immediately after retrieval of the Colovac+ Device in order to check for anastomotic integrity following device retrieval.

    Outcome is measured with presence/absence of any contrast liquid leak through the anastomosis after device retrieval.

    Measured: 10 days

  10. To measure the average procedure time

    The average procedure time at the day of implantation

    Measured: 1 day

  11. To measure the patient tolerability of the device using a patient questionnaire

    Responses to a patient questionnaire on device acceptance, on the device handling and comfort, and on preference compared to an ostomy - utilizing the NIH's (National Institute of Health) PROMIS (Patient-Reported Outcomes Measurement Information System) health measurement questionnaires to assess parameters like pain, bowel incontinence, constipation, diarrhea, or anxiety and social isolation, on a scale from 1 to 10 (1 being absence of difficulty and 10 being severe problems).

    Measured: 10 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jan 2022
  2. Study start18 Dec 2019
  3. Primary completion28 Feb 2022
  4. Study completion31 Mar 2022

Resources

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
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
27 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05180565
Sponsor's protocol ID
SAFE2019
Acronym
SAFE2019
Status last verified
Apr 2026
First submitted
26 Oct 2021
Last updated
1 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Sylla P, Lam K, Komen N, Tuech JJ, Spinelli A, Martz J, Rhee R, Marcet J, Cadiere GB, Rouanet P, Karachun A, Denost Q, Sametdinov N, D'Hoore A, Lee S, Lefevre JH. Safety and Performance of the Colovac Anastomosis Protection Device. A Pooled Analysis of Prospective Studies Compared With Diverting Loop Ileostomy (SAFE-2025). Ann Surg. 2026 Sep 2. doi: 10.1097/SLA.0000000000007171. Online ahead of print.

    PubMed 42681563

  • De Hous N, D'Urso A, Cadiere GB, Cadiere B, Rouanet P, Komen N, Lefevre JH. Evaluation of the SafeHeal Colovac+ anastomosis protection device after low anterior resection for rectal cancer: the safe anastomosis feasibility evaluation (SAFE) 2019 trial. Surg Endosc. 2023 Sep;37(9):7385-7392. doi: 10.1007/s00464-023-10272-x. Epub 2023 Jul 18.

    PubMed 37464064

Questions about this trial

What is this clinical trial studying?

A study testing Colovac in people with Colorectal Cancer and Anastomosis, run by SafeHeal Inc at 7 sites in 2 countries.

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 3 inclusion and 25 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 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in France, Belgium. 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?

To measure the incidence of serious adverse events related to using the device (time frame: 3 months). 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 NCT05180565, which also lists 2 linked publications.

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 1 May 2026; AzTrials last refreshed its copy on 28 Oct 2026.

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