Colovac Device for Colorectal Cancer

(SAFE-3CV Trial)

Enrolling by invitation at 12 trial locations

Overseen By Heather Cronin

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: SafeHeal Inc

Must not be taking: Steroids, Antimicrobials

Disqualifiers: Active colitis, Nickel allergy, Pregnancy, Immunodeficiency, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 10 days

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial focuses on testing the Colovac Device, which protects the area where the colon is reconnected after colorectal cancer surgery. The researchers aim to assess the safety and effectiveness of this device for patients undergoing this type of surgery. They seek participants eligible for specific colorectal surgeries who do not have conditions like active colitis or severe malnutrition. Those with planned colorectal cancer surgery who meet these criteria might find this trial suitable. As an unphased trial, it offers a unique opportunity to contribute to medical advancements and potentially benefit from innovative care.

What prior data suggests that the Colovac Device is safe for colorectal cancer patients?

Studies have shown that the Colovac Anastomosis Protection Device is generally safe for patients undergoing colorectal surgery. Research indicates that Colovac effectively protects the reconnection site of the colon, which is crucial for recovery. In another study, the device reduced the need for additional surgeries in up to 73% of patients. This suggests that the device is well-tolerated and can help reduce complications. While no treatment is entirely risk-free, the evidence so far supports the safety of the Colovac device in these medical situations. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Colovac Device because it offers a new way to protect the colon after surgery for colorectal cancer. Unlike traditional methods that may involve temporary stomas, the Colovac Device is designed to shield the anastomosis (the surgical connection between two parts of the colon) without needing an external bag. This approach aims to improve recovery by reducing complications and enhancing patient comfort post-surgery. By potentially eliminating the need for a stoma, the Colovac Device could make life after surgery much easier for patients.

What evidence suggests that the Colovac Device is effective for colorectal cancer?

Research has shown that the Colovac Anastomosis Protection Device, which participants in this trial will receive, effectively protects the surgical connection in the colon. In an early study, the device successfully protected these connections in all 15 patients. This suggests it may help prevent leaks after colorectal surgery, a serious complication. Other studies have found that Colovac can aid in faster recovery by eliminating the need for a temporary opening (stoma) in the abdomen. These findings suggest that Colovac could offer a safer and more comfortable option for those undergoing colorectal surgery. ^{1 3 4 6 7}

Are You a Good Fit for This Trial?

This trial is for adults aged 22 or older with colorectal cancer who are fit enough (ECOG ≤ 2) to undergo a specific type of bowel surgery called low anterior resection with ileostomy. Participants must be willing to follow the study's procedures and sign consent.

Inclusion Criteria

I can perform daily activities with minimal assistance.

Willingness to comply with protocol-specific treatment and study visits and to sign a written Informed Consent Form

I am 22 years old or older.

Exclusion Criteria

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:

Blood loss (>750 cc)

Positive air leak test

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Subjects treated with the Colovac Device following low anterior resection of the colon

10 days

1 visit (in-person) at Day 10

Follow-up

Participants are monitored for safety and effectiveness after treatment

9 months

What Are the Treatments Tested in This Trial?

Interventions

• Colovac Anastomosis Protection Device

Trial Overview

The study tests the Colovac Anastomosis Protection Device, which is used after colon cancer surgery to protect the surgical connection between two parts of the intestine. The goal is to see if it can reduce complications.

How Is the Trial Designed?

Group I: Colovac arm Experimental Treatment 1 Intervention

Subjects treated with the Colovac Device following low anterior resection of the colon will be enrolled in the investigational cohort.

Who Is Running the Clinical Trial?

SafeHeal Inc

Lead Sponsor

Trials

4

Recruited

270+

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/38750621/

SafeHeal Colovac Colorectal Anastomosis Protection ...

A preliminary study (SAFE-1) completed in three European centres demonstrated 100% protection of colorectal anastomoses in 15 patients, as evidenced by the ...

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07116668

NCT07116668 | SafeHeal Colovac Anastomosis Protection ...

This study aims to further assess the safety and effectiveness of the Colovac Anastomosis Protection Device, a temporary intraluminal bypass device, on a ...

3.

sofinnovapartners.com

sofinnovapartners.com/news/SafeHeal%C2%AE%20Announces%20Successful%20Launch%20of%20SAFE-3CV%20IDE%20Study%20for%20Colovac%C2%AE%20Anastomosis%20Protection%20Technology

SafeHeal® Announces Successful Launch of SAFE-3CV ...

Breakthrough device promises significantly improved patient recovery after colorectal surgery. January 12, 2026 – SafeHeal®, ...

4.

safeheal.com

safeheal.com/wp-content/uploads/2023/09/safe-2019-evaluation-of-safeheal-colovac-anastomosis-protection-device.pdf

Evaluation of the SafeHeal Colovac+ anastomosis ...

Conclusions Colovac+ provides a safe and effective protection of the anastomosis after LAR, and avoids the PI in the major- ity (73%) of patients. The improved ...

5.

safeheal.com

safeheal.com/product/europe/

The Clinical Benefits of SafeHeal Products for ...

Clinical trial evidence supports Colovac's effectiveness as an alternative to diverting stoma, improving and expediting patient recovery from colorectal surgery ...

6.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07116668

NCT07116668 | SafeHeal Colovac Anastomosis Protection ...

This study aims to further assess the safety and effectiveness of the Colovac Anastomosis Protection Device, a temporary intraluminal bypass ...

7.

omicsdi.org

omicsdi.org/dataset/ecrin-mdr-crc/2387068

SafeHeal Colovac Colorectal Anastomosis Protection ...

ABSTRACT: A randomized trial to assess the safety and effectiveness of the Colovac in providing temporary protection of the anastomosis in subjects ...