The SAFE-3CV study is enrolling at 14 sites across the U.S. Select your nearest site and start your instant virtual screening.
Start Instant Screening — Under 5 MinSafeHeal, the manufacturer of Colovac, is currently enrolling patients in a clinical study at up to 25 leading academic medical centers in the United States and Europe. This study will investigate the performance and safety of the Colovac device as an alternative to a diverting ostomy for patients undergoing surgical treatment of rectal cancer. Colovac has been studied in over 80 patients in multiple pilot clinical trials in the United States, Europe, and Asia. In recent trials, greater than 85% of participating patients successfully avoided a diverting ostomy.
Rectal cancer resection — cancer removed, colon rejoined
A temporary ostomy diverts stool to an external pouch
You may be eligible to participate if you are:
Speak to your surgeon to confirm that you meet the inclusion and exclusion criteria for this study.
Colovac is an investigational device designed to provide protection of the anastomosis during the critical 10-day post-operative healing stage, giving the majority of patients the benefit of avoiding a diverting ostomy and the second surgery to reverse it.
Avoid an ostomy and the associated physical and quality-of-life challenges
Avoid a second hospitalization and surgery to reverse the ostomy
Return to your normal activity faster after your cancer resection surgery
In a feasibility study, 86% of Colovac patients avoided an ostomy.1
1SAFE-2023 Feasibility Study. In the U.S., the Colovac device is only available as part of this clinical study.
Select your site above, then answer 3 quick questions.
No cost · No commitment · Results on the spot
You will receive the same cancer surgery and treatment as if you were not participating in the study. The key difference happens after the diseased part of your colon is removed.
| Before Surgery | Your care team will confirm your eligibility to participate and have you sign a consent form. |
| During Surgery | After the diseased part of your colon is removed, the Colovac device will be placed in the colon instead of the surgeon creating an ostomy. |
| After Surgery ~10 Days | You will be monitored in the hospital for about 10 days while your colon heals with the Colovac device in place. The care team will check on you twice per day. |
| Device Removal | After about 10 days, the healing of your colon will be assessed by a CT scan and the Colovac device will be removed endoscopically — a non-surgical procedure like a colonoscopy. |
| Follow-Up | Follow-up check-ins at 1, 3, 6, 9, and 12 months — consistent with typical cancer care. Some may be conducted by phone. |
Participants receive $1,200 compensation for completing required follow-up steps, with no additional cost to participate in the SAFE-3CV study. Follow-up check-ins are scheduled at 1, 3, 6, 9, and 12 months — some may be conducted by phone.
