Colorectal CancerSAFE-2NCT05010850
SafeHeal Colovac Colorectal Anastomosis Protection Device Evaluation (SAFE-2) Pivotal Study
A study testing Colovac and Stoma Creation in people with Colorectal Cancer and Rectal Cancer, run by SafeHeal Inc at 16 sites in 3 countries.
Trial summary
A randomized trial to assess the safety and effectiveness of the Colovac 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, Rectal Cancer, Rectal Tumor
- What is being tested?
- Colovac and Stoma Creation
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 16 sitesin 3 countries
- Study dates
- 17 Jan 2022to 19 Jan 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 (greater than 18 years of age)
- Eligible to undergo open or minimally invasive sphincter-preserving lower anterior resection (anastomosis within 10 cm of the anal verge) with planned diverting loop ileostomy for malignant indication, assessed by a multi-disciplinary team.
- Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2
- Willing to comply with protocol-specific treatment and study visits and to sign a written Informed Consent Form
Who cannot join
- History of left colitis
- 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 (e.g.. 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 protocol described procedures or interfere with the interpretation of study results. including, but not limited to:
- COVID-19 positive (active infection) if test required by hospital
Show all 23Show fewer
- Immunodeficiency (CD4+ count < 500 mm3)
- 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
- Stage IV colorectal cancer unless curative intent R0 resection is planned AND there is no associated peritoneal disease
- The subject is currently participating in another investigational drug or device study
- 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
- Inadequate bowel preparation
- Anastomosis location greater than 10 cm from the anal verge
- Other intra-operative risks that preclude the subject from undergoing the procedure with the investigational device
Trial locations and contacts
16 sites in 3 countries.
16 sites in 3 countries
United States10 sites
Maimonides Medical Center
Brooklyn, New York, 11219
Dartmouth-Hitchcock
Lebanon, New Hampshire, 03756
Kaiser Permanente - Los Angeles
Los Angeles, California, 90027
USC Keck Hospital
Los Angeles, California, 90033
Cedars-Sinai Medical Center
Los Angeles, California, 90048
Mount Sinai Hospital
New York, New York, 10029
Lenox Hill Hospital
New York, New York, 10075
Tampa General Hospital
Tampa, Florida, 33606
UMass Memorial Medical Center
Worcester, Massachusetts, 01605
Lankenau Medical Center
Wynnewood, Pennsylvania, 19096
France5 sites
CHU de Besancon
Besançon, 25030
ICM Val d'Aurelle
Montpellier, 34090
Hopital Saint-Louis
Paris, 75010
Hôpital Saint Antoine Paris
Paris, Île-de-France Region, 75571
CHU Rouen Normandie
Rouen, 76031
About this study
Official title: SafeHeal Colovac Colorectal Anastomosis Protection Device Evaluation (SAFE-2) Pivotal Study: A Study to Evaluate the Safety and Effectiveness of the Colovac Colorectal Anastomosis Protection Device
A randomized trial to assess the safety and effectiveness of the Colovac 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.
- Conditions
- Colorectal Cancer, Rectal Cancer, Rectal Tumor, Rectal/Anal
- Being tested
- Colovac, Stoma Creation
- Keywords
- anastomosis, leak, colorectal, ileostomy
- Medical subject headings
- Colorectal Neoplasms, Rectal 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)
Stoma CreationProcedure or surgery
Protective ileostomy
| Study group | Role | What they receive |
|---|---|---|
| Colovac | Experimental | Patients receive Colovac during colorectal surgery Receives: Device: Colovac |
| Standard of Care | Active comparator | Patients receive the standard of care, a protective stoma, during colorectal surgery Receives: Procedure: Stoma Creation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Avoidance of Ostomy
Reduction in stoma creation rate
Measured: 12 Months
Safety Major Complications
Rate of subjects with major complications
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2021
- Study start17 Jan 2022
- Primary completion19 Jan 2024
- Study completion19 Jan 2024
Why it stopped: Voluntary and temporary suspension of enrollment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- SafeHeal Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Patricia Sylla, MD, Principal investigator, MOUNT SINAI HOSPITALJeremie Lefevre, MD, PhD, Principal investigator, Hopital Saint Antoine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05010850
- Sponsor's protocol ID
- SAFE-2
- Acronym
- SAFE-2
- Status last verified
- Jun 2025
- First submitted
- 11 Aug 2021
- Last updated
- 3 Jul 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- 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 42681563Hain E, Lefevre JH, Ricardo A, Lee S, Zaghiyan K, McLemore E, Sherwinter D, Rhee R, Wilson M, Martz J, Maykel J, Marks J, Marcet J, Rouanet P, Maggiori L, Komen N, De Hous N, Lakkis Z, Tuech JJ, Attiyeh F, Cotte E, Sylla P. SafeHeal Colovac Colorectal Anastomosis Protection Device evaluation (SAFE-2) pivotal study: an international randomized controlled study to evaluate the safety and effectiveness of the Colovac Colorectal Anastomosis Protection Device. Colorectal Dis. 2024 Jun;26(6):1271-1284. doi: 10.1111/codi.17012. Epub 2024 May 15.
PubMed 38750621
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SafeHeal Colovac Colorectal Anastomosis Protection Device Evaluation (SAFE-2) Pivotal Study: A Study to Evaluate the Safety and Effectiveness of the Colovac Colorectal Anastomosis Protection Device
- ClinicalTrials.gov ID
- NCT05010850
- Acronym / sponsor ID
- SAFE-2 / SAFE-2
- Conditions
- Colorectal Cancer, Rectal Cancer, Rectal Tumor, Rectal/Anal
- Keywords
- anastomosis, leak, colorectal, ileostomy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Voluntary and temporary suspension of enrollment.
- Enrolment
- 18 participants (actual)
- Lead sponsor
- SafeHeal IncIndustry (pharma, biotech, devices)
- Study start
- 17 Jan 2022 (actual)
- Primary completion
- 19 Jan 2024 (actual)
- Study completion
- 19 Jan 2024 (actual)
- First posted
- 18 Aug 2021 (actual)
- Results
- Posted 3 Jul 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A randomized trial to assess the safety and effectiveness of the Colovac in providing temporary protection of the anastomosis in subjects undergoing lower anterior resection for colorectal cancer.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Colovac | Experimental | Device: ColovacPatients receive Colovac during colorectal surgery |
| Standard of Care | Active comparator | Procedure: Stoma CreationPatients receive the standard of care, a protective stoma, during colorectal surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult patients (greater than 18 years of age)
- Eligible to undergo open or minimally invasive sphincter-preserving lower anterior resection (anastomosis within 10 cm of the anal verge) with planned diverting loop ileostomy for malignant indication, assessed by a multi-disciplinary team.
- Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2
- Willing to comply with protocol-specific treatment and study visits and to sign a written Informed Consent Form
Key exclusion criteria (23 listed)
- History of left colitis
- 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 (e.g.. 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 protocol described procedures or interfere with the interpretation of study results. including, but not limited to:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ColovacA 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) | Device | Colovac |
| Stoma CreationProtective ileostomy | Procedure or surgery | Standard of Care |
Primary outcome
Avoidance of Ostomy
Time frame: 12 Months
Reduction in stoma creation rate
Safety Major Complications
Time frame: 12 Months
Rate of subjects with major complications
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42681563Sylla 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.
- Derived from this study: PubMed 38750621Hain E, Lefevre JH, Ricardo A, Lee S, Zaghiyan K, McLemore E, Sherwinter D, Rhee R, Wilson M, Martz J, Maykel J, Marks J, Marcet J, Rouanet P, Maggiori L, Komen N, De Hous N, Lakkis Z, Tuech JJ, Attiyeh F, Cotte E, Sylla P. SafeHeal Colovac Colorectal Anastomosis Protection Device evaluation (SAFE-2) pivotal study: an international randomized controlled study to evaluate the safety and effectiveness of the Colovac Colorectal Anastomosis Protection Device. Colorectal Dis. 2024 Jun;26(6):1271-1284. doi: 10.1111/codi.17012. Epub 2024 May 15.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patricia Sylla, MD principal investigator
MOUNT SINAI HOSPITAL
Jeremie Lefevre, MD, PhD principal investigator
Hopital Saint Antoine
16 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Colovac and Stoma Creation in people with Colorectal Cancer and Rectal Cancer, run by SafeHeal Inc at 16 sites in 3 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 4 inclusion and 23 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: stopped early, as of the sponsor's last update on 3 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in United States, 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?
Yes. Results are posted in the registry (first posted 3 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Avoidance of Ostomy (time frame: 12 Months). The study lists 2 primary outcomes in all. 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 NCT05010850, 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 3 Jul 2025.