SafeHeal Colovac Anastomosis Protection Device Evaluation Pivotal Study
Public ClinicalTrials.gov record NCT07116668. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 identification
- NCT ID
- NCT07116668
- Recruitment status
- Enrolling by invitation
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 108 participants
Conditions and interventions
Conditions
Interventions
- Colovac Anastomosis Protection Device placement following low anterior resection of colon cancer Device
Device
Eligibility (public fields only)
- Age range
- 22 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jan 8, 2026 (Actual)
- Primary completion
- Dec 2026 (Estimated)
- Completion
- Jul 2027 (Estimated)
- Last update posted
- Apr 29, 2026
2026 – 2027
United States locations
- U.S. sites
- 12
- U.S. states
- 6
- U.S. cities
- 10
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Keck Medicine of USC | Los Angeles | California | 90033 | — |
| Cedars-Sinai Medical Center | Los Angeles | California | 90048 | — |
| University of Miami | Miami | Florida | 33146 | — |
| Tampa General Hospital | Tampa | Florida | 33606 | — |
| Boston Medical Center | Boston | Massachusetts | 02118 | — |
| University of Massachusetts | Worcester | Massachusetts | 01605 | — |
| Maimonides Medical Center | Brooklyn | New York | 11219 | — |
| Mount Sinai Hospital | New York | New York | 10029 | — |
| Lenox Hill Hospital | New York | New York | 10075 | — |
| Novant Health | Winston-Salem | North Carolina | 27103 | — |
| Geisinger Medical Center | Danville | Pennsylvania | 17822 | — |
| Lankenau Medical Center | Wynnewood | Pennsylvania | 19096 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 6 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT07116668, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Apr 29, 2026 · Synced Oct 24, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT07116668 live on ClinicalTrials.gov.