NCT03352570 (SAFE-1) is a NA clinical trial of COLOVAC in Gastrointestinal Anastomotic Complication, sponsored by Safeheal.

Who is sponsoring NCT03352570?

NCT03352570 is sponsored by Safeheal.

What drugs are being tested in NCT03352570?

Interventions in NCT03352570: COLOVAC.

What condition does NCT03352570 study?

NCT03352570 studies Gastrointestinal Anastomotic Complication.

Is NCT03352570 still recruiting?

NCT03352570 is currently completed. Last updated 10 October 2019.

Last reviewed 2019-10-10 · How we verify

NCT03352570: SAFE-1

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

a Study to Investigate the Efficacy, and Safety of the Colovac Colorectal Anastomosis Protection Device.

Completed NA Last updated 10 October 2019

What this trial tests

NA trial testing COLOVAC in Gastrointestinal Anastomotic Complication in 15 participants. Completed in 26 March 2019.

Timeline

14 November 2017

Primary endpoint
26 September 2018

26 March 2019

Quick facts

Lead sponsor	Safeheal
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	device feasibility
Enrollment	15
Start date	14 November 2017
Primary completion	26 September 2018
Estimated completion	26 March 2019
Sites	3 locations across Belgium, France

Drugs / interventions tested

COLOVAC

Conditions studied

Gastrointestinal Anastomotic Complication — all drugs for Gastrointestinal Anastomotic Complication →

Sponsor

Safeheal

Who can join

Adults 18 to 65, any sex, with Gastrointestinal Anastomotic Complication. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The purpose of this study is to evaluate theColovac device, a single use, temporary intraluminal bypass device,intended to reduce contact of fecal content with an anastomotic site, following colorectal surgery (open or laparoscopic).

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Advanced innovations in reducing anastomotic leak: a review of emerging biomaterial applications in colorectal surgery.
Chen E, Chen L, Zhang W, Zhou W. · · 2025 · PMID 41051406 · DOI 10.1007/s00384-025-04930-w

Verify or expand the search:

Other Safeheal trials

Trials by the same sponsor.

NCT04359498 — Retrospective Study of Surgical Complications in Patients With Defunctioning Stoma After Low Anterior Resection (LAR) · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03352570 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Safeheal
Last refreshed: 10 October 2019

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03352570.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing