Colorectal CancerSAFE-3CVNCT07116668
SafeHeal Colovac Anastomosis Protection Device Evaluation Pivotal Study
A study testing Colovac Anastomosis Protection Device placement following low anterior resection of colon cancer in people with Colorectal Cancer and Stoma - Ileostomy, run by SafeHeal Inc at 18 sites in 4 countries.
Trial summary
Colorectal cancer is the third most common malignancy worldwide and the second most common in the US. It is the second leading cause of cancer death worldwide, with 1.8 million new cases and 862,000 deaths per year. The majority of patients receive surgical treatment. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Colorectal Cancer, Stoma - Ileostomy
- What is being tested?
- Colovac Anastomosis Protection Device placement following low anterior resection of colon cancer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 18 sitesin 4 countries
- Study dates
- 8 Jan 2026to Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A subject meeting all of the following criteria will be considered for participation in the study:
- Adult patients (22 years of age or older)
- Eligible to undergo open or minimally invasive sphincter-sparing low anterior resection with planned diverting loop ileostomy for malignancy.
- Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2
- Willingness to comply with protocol-specific treatment and study visits and to sign a written Informed Consent Form
Who cannot join
- Preoperative:
- Active colitis
- Known allergy to nickel or other components of the Colovac system
- 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 protocol-described procedures or interfere with the interpretation of study results including, but not limited to:
Show all 24Show fewer
- Stage IV colorectal cancer unless curative intent R0 resection is planned AND there is no associated peritoneal disease
- Immunodeficiency (CD4+ count < 500 CU MM)
- Systemic and ongoing 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, or 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 that may confound the results of SAFE-3CV. Prior approval from SafeHeal Medical Monitor must be obtained prior to enrollment in SAFE-3CV.
- Intraoperatively:
- Occurrence of any of the following during the colorectal surgery:
- Blood loss (>750 cc)
- Blood transfusion
- Any new sign of bowel ischemia
- Positive air leak test
- Inadequate bowel preparation
- Anastomosis location greater than 10 cm from the anal verge
- Any other surgical complications or intra-operative risks that may place the patient at greater risk from study procedures
Trial locations and contacts
18 sites in 4 countries. Contact the study team or a site near you to ask about taking part.
18 sites in 4 countries
United States12 sites
Boston Medical Center
Boston, Massachusetts, 02118
Maimonides Medical Center
Brooklyn, New York, 11219
Geisinger Medical Center
Danville, Pennsylvania, 17822
Keck Medicine of USC
Los Angeles, California, 90033
Cedars-Sinai Medical Center
Los Angeles, California, 90048
University of Miami
Miami, Florida, 33146
Mount Sinai Hospital
New York, New York, 10029
Lenox Hill Hospital
New York, New York, 10075
Tampa General Hospital
Tampa, Florida, 33606
Novant Health
Winston-Salem, North Carolina, 27103
University of Massachusetts
Worcester, Massachusetts, 01605
Lankenau Medical Center
Wynnewood, Pennsylvania, 19096
France3 sites
Bordeaux Colorectal Institute
Bourdeaux, New Aquitaine, 33000
Hopital Saint-Antoine
Paris, Île-de-France Region, 75012
Chu du Rouen
Rouen, Normandy, 76031
Belgium2 sites
UZA
Edegem, Antwerp, 2650
UZ Leuven
Leuven, Flemish Brabant, 3000
About this study
Official title: SafeHeal Colovac Anastomosis Protection Device Evaluation (SAFE-3CV) Pivotal Study: A Study to Evaluate Safety and Effectiveness of the Colovac Anastomosis Protection Device
Colorectal cancer is the third most common malignancy worldwide and the second most common in the US. It is the second leading cause of cancer death worldwide, with 1.8 million new cases and 862,000 deaths per year. The majority of patients receive surgical treatment. Colorectal surgery is associated with a high risk of morbidity and mortality in comparison to other general surgery subspecialties. This study aims to further assess the safety and effectiveness of the Colovac Anastomosis Protection Device, a temporary intraluminal bypass device, on a larger scale.
Read the detailed description
The Colovac Anastomosis Protection Device is intended for use in patients requiring low anterior rectal anastomoses to limit stoma creation to only those patients requiring more time for anastomosis healing when the device is removed, allowing patients with a healed anastomosis to avoid stoma creation. To reduce the risk of life-threatening complications, Colovac provides an alternative to stoma creation which prevents stoma related risks, including permanent stoma.
- Conditions
- Colorectal Cancer, Stoma - Ileostomy
- Being tested
- Colovac Anastomosis Protection Device placement following low anterior resection of colon cancer
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Colovac Anastomosis Protection Device placement following low anterior resection of colon cancerDevice
Subjects in the Investigational cohort (SAFE-3CV) will undergo an LAR procedure followed by Colovac placement. Colovac retrieval will then occur at ~10 days post LAR procedure.
| Study group | Role | What they receive |
|---|---|---|
| Colovac arm | Experimental | Subjects treated with the Colovac Device following low anterior resection of the colon will be enrolled in the investigational cohort. Receives: Device: Colovac Anastomosis Protection Device placement following low anterior resection of colon cancer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance: Clinically meaningful ostomy avoidance rate at Day 10
The primary performance endpoint assessed for Colovac subjects at the Day 10 visit is a clinically meaningful ostomy avoidance rate that supports a favorable benefit risk when considering the primary safety endpoint.
Measured: at 10 day visit
Safety: Cumulative rate of Major Complications
The primary safety endpoint is the cumulative rate of subjects with major complications through 9 months.
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2025
- Study start8 Jan 2026
- Primary completionDec 2026 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Not applicable
- Intervention model
- Single group
- Model description
- The SafeHeal Colovac Anastomosis Protection Device Evaluation (SAFE-3CV) Pivotal Study is a prospective, non-randomized, sequential, IDE multicenter trial enrolling patients who are implanted with the investigational device, the Colovac Anastomosis Protection Device (next generation). These patients will be compared to a control group, the standard of care (diverting ostomy) and analyzed using a propensity subclassification approach with pre-specified covariates. The control data were collected as part of the SH-SOC23 study, a prospective, non-randomized, multicenter study sponsored by SafeHeal.
- Masking
- None (open label)
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SafeHeal Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07116668
- Sponsor's protocol ID
- SAFE-3CV
- Acronym
- SAFE-3CV
- Status last verified
- Apr 2026
- First submitted
- 7 Aug 2025
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: The data is confidential and only available upon a reasonable request.
Publications
Pastier C, Sylla P, Lee SW, Spinelli A, Komen N, Marks J, Martz J, Rhee R, Maykel J, Marcet J, Denost Q, Zaghiyan K, Davids JS, Paluvoi N, Hiller D, McLemore EC, Maggiori L, D'hoore A, Jafari MD, Poylin V, Buzas CJ, Tuech JJ, Lefevre JH. Safety and effectiveness of the Colovac anastomosis protection device compared with diverting ileostomy after low anterior resection: protocol for an international, multicentre, prospective, non-randomised comparative study (SAFE-3). BMJ Open Gastroenterol. 2026 Jun 12;13(1):e002235. doi: 10.1136/bmjgast-2025-002235.
PubMed 42285586
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SafeHeal Colovac Anastomosis Protection Device Evaluation (SAFE-3CV) Pivotal Study: A Study to Evaluate Safety and Effectiveness of the Colovac Anastomosis Protection Device
- ClinicalTrials.gov ID
- NCT07116668
- Acronym / sponsor ID
- SAFE-3CV / SAFE-3CV
- Conditions
- Colorectal Cancer, Stoma - Ileostomy
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- SafeHeal IncIndustry (pharma, biotech, devices)
- Study start
- 8 Jan 2026 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 11 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Colorectal cancer is the third most common malignancy worldwide and the second most common in the US. It is the second leading cause of cancer death worldwide, with 1.8 million new cases and 862,000 deaths per year. The majority of patients receive surgical treatment. Colorectal surgery is associated with a high risk of morbidity and mortality in comparison to other general surgery subspecialties. This study aims to further assess the safety and effectiveness of the Colovac Anastomosis Protection Device, a temporary intraluminal bypass device, on a larger scale.
Detailed description
The Colovac Anastomosis Protection Device is intended for use in patients requiring low anterior rectal anastomoses to limit stoma creation to only those patients requiring more time for anastomosis healing when the device is removed, allowing patients with a healed anastomosis to avoid stoma creation. To reduce the risk of life-threatening complications, Colovac provides an alternative to stoma creation which prevents stoma related risks, including permanent stoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The SafeHeal Colovac Anastomosis Protection Device Evaluation (SAFE-3CV) Pivotal Study is a prospective, non-randomized, sequential, IDE multicenter trial enrolling patients who are implanted with the investigational device, the Colovac Anastomosis Protection Device (next generation). These patients will be compared to a control group, the standard of care (diverting ostomy) and analyzed using a propensity subclassification approach with pre-specified covariates. The control data were collected as part of the SH-SOC23 study, a prospective, non-randomized, multicenter study sponsored by SafeHeal.
| Arm | Type | Receives |
|---|---|---|
| Colovac arm | Experimental | Device: Colovac Anastomosis Protection Device placement following low anterior resection of colon cancerSubjects treated with the Colovac Device following low anterior resection of the colon will be enrolled in the investigational cohort. |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- A subject meeting all of the following criteria will be considered for participation in the study:
- Adult patients (22 years of age or older)
- Eligible to undergo open or minimally invasive sphincter-sparing low anterior resection with planned diverting loop ileostomy for malignancy.
- Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2
- Willingness to comply with protocol-specific treatment and study visits and to sign a written Informed Consent Form
Key exclusion criteria (24 listed)
- Preoperative:
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 |
|---|---|---|
| Colovac Anastomosis Protection Device placement following low anterior resection of colon cancerSubjects in the Investigational cohort (SAFE-3CV) will undergo an LAR procedure followed by Colovac placement. Colovac retrieval will then occur at ~10 days post LAR procedure. | Device | Colovac arm |
Primary outcome
Performance: Clinically meaningful ostomy avoidance rate at Day 10
Time frame: at 10 day visit
The primary performance endpoint assessed for Colovac subjects at the Day 10 visit is a clinically meaningful ostomy avoidance rate that supports a favorable benefit risk when considering the primary safety endpoint.
Safety: Cumulative rate of Major Complications
Time frame: 9 months
The primary safety endpoint is the cumulative rate of subjects with major complications through 9 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
- Derived from this study: PubMed 42285586Pastier C, Sylla P, Lee SW, Spinelli A, Komen N, Marks J, Martz J, Rhee R, Maykel J, Marcet J, Denost Q, Zaghiyan K, Davids JS, Paluvoi N, Hiller D, McLemore EC, Maggiori L, D'hoore A, Jafari MD, Poylin V, Buzas CJ, Tuech JJ, Lefevre JH. Safety and effectiveness of the Colovac anastomosis protection device compared with diverting ileostomy after low anterior resection: protocol for an international, multicentre, prospective, non-randomised comparative study (SAFE-3). BMJ Open Gastroenterol. 2026 Jun 12;13(1):e002235. doi: 10.1136/bmjgast-2025-002235.
- Individual participant dataSharing planned: No. The data is confidential and only available upon a reasonable request.
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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.
The record lists no contact. Use the official record to reach the sponsor.
18 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Colovac Anastomosis Protection Device placement following low anterior resection of colon cancer in people with Colorectal Cancer and Stoma - Ileostomy, run by SafeHeal Inc at 18 sites in 4 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 5 inclusion and 24 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: enrolling by invitation, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in United States, France, Belgium, Italy. 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?
This study is still under way. Results are not available in the source record yet.
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?
Performance: Clinically meaningful ostomy avoidance rate at Day 10 (time frame: at 10 day visit). 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 NCT07116668, which also lists 1 linked publication.
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 29 Apr 2026.