SafeHeal Colovac Anastomosis Protection Device Evaluation Pivotal Study (SAFE-3CV)

April 27, 2026 updated by: SafeHeal Inc

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Enrolling by invitation

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
108

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Belgium
    • Antwerp
      • Edegem, Antwerp, Belgium, 2650
        • UZA
    • Flemish Brabant
      • Leuven, Flemish Brabant, Belgium, 3000
        • UZ Leuven
  • France
    • New Aquitaine
      • Bourdeaux, New Aquitaine, France, 33000
        • Bordeaux Colorectal Institute
    • Normandy
      • Rouen, Normandy, France, 76031
        • Chu du Rouen
    • Île-de-France Region
      • Paris, Île-de-France Region, France, 75012
        • Hôpital Saint-Antoine
  • Italy
    • Lombardi
      • Rozzano, Lombardi, Italy, 20089
        • Humanitas Research Hospital
  • United States
    • California
      • Los Angeles, California, United States, 90048
        • Cedars-Sinai Medical Center
      • Los Angeles, California, United States, 90033
        • Keck Medicine of USC
    • Florida
      • Miami, Florida, United States, 33146
        • University of Miami
      • Tampa, Florida, United States, 33606
        • Tampa General Hospital
    • Massachusetts
      • Boston, Massachusetts, United States, 02118
        • Boston Medical Center
      • Worcester, Massachusetts, United States, 01605
        • University of Massachusetts
    • New York
      • Brooklyn, New York, United States, 11219
        • Maimonides Medical Center
      • New York, New York, United States, 10029
        • Mount Sinai Hospital
      • New York, New York, United States, 10075
        • Lenox Hill Hospital
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27103
        • Novant Health
    • Pennsylvania
      • Danville, Pennsylvania, United States, 17822
        • Geisinger Medical Center
      • Wynnewood, Pennsylvania, United States, 19096
        • Lankenau Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Colovac arm
Subjects treated with the Colovac Device following low anterior resection of the colon will be enrolled in the investigational cohort.
Device: Colovac Anastomosis Protection Device placement following low anterior resection of colon cancer
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
at 10 day visit
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.
9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
SafeHeal Inc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 8, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 7, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 7, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 11, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 29, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 27, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SAFE-3CV

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The data is confidential and only available upon a reasonable request.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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