Safe Anastomosis Feasibility Study
SAFE2019
1 other identifier
interventional
27
2 countries
7
Brief Summary
A clinical trial to assess the efficacy, mechanism of action and safety of the Colovac+ Colorectal Anastomosis Protection Device in providing temporary protection of the anastomosis in subjects undergoing lower anterior resection for colorectal cancer
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable colorectal-cancer
Started Dec 2019
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 18, 2019
CompletedFirst Submitted
Initial submission to the registry
October 26, 2021
CompletedFirst Posted
Study publicly available on registry
January 6, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 28, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2022
CompletedMay 1, 2026
April 1, 2026
2.2 years
October 26, 2021
April 27, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To measure the incidence of serious adverse events related to using the device
The primary endpoint will be a measurement of SAEs probably related or causaly related to the use of the investigational device, to the index surgery in this clinical trial.
3 months
Secondary Outcomes (11)
To measure the number of participants with evidence of absence of feces between the sheath and the colonic wall before device retrieval
10 days
To measure the rate of ostomy avoidance
3 months
To evaluate the occurrence of clinical anastomotic leakage
3 months
To measure on a scale of 1 to 5 rated by the surgeon the ease of device introduction, positioning and endoscopic retrieval
10 days
To evaluate the clinically significant migration rate
10 days
- +6 more secondary outcomes
Study Arms (1)
Colovac
EXPERIMENTALPatients receive Colovac device during colorectal surgery
Interventions
A removable, temporary intraluminal bypass device designed to safely postpone the creation of a protective stoma until 10 days after surgery for only patients who need it (do not have a healed anastomosis)
Eligibility Criteria
You may qualify if:
- Adult patients (18 years of age or older)
- Eligible to undergo open or minimally invasive sphincter-sparing low anterior resection with planned diverting loop ileostomy for malignancy, based on multidisciplinary team recommendations.
- Willingness to comply with Clinical Investigation Plan-specific treatment and study visits and to sign a written Informed Consent Form
You may not qualify if:
- \- Preoperatively :
- Patient with inflammatory bowel disease
- Known allergy to nickel or other components of the Colovac+ kit
- Pregnant or nursing female subject
- Concomitant major surgical procedure in combination with Colorectal resection (i.e. hepatectomy)
- 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 Clinical Investigation Plan described procedures or interfere with the interpretation of study results. including, but not limited to:
- COVID-19 positive (active infection) based on test within 72 hours prior to surgery
- Metastatic disease - unless previously treated with chemotherapy and resection, and the benefit of exposure to the Colovac device is greater than the risk 1
- Immunodeficiency (CD4+ count \< 500 CU MM)
- Systemic steroid therapy within the past 6 months
- Systemic infection at the time of surgery or requiring systemic antimicrobial therapy up to 1 week before surgery
- 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
- Diagnosis of bowel obstruction, bowel strangulation, peritonitis, bowel perforation, intraabdominal infection, ischemic bowel, carcinomatosis
- Fecal incontinence, involvement of sphincter by the neoplastic disease or evidence of extensive local disease in the pelvis seen on pre-operative imaging
- Severe Malnutrition defined as 10% weight loss within 3 months prior to enrollment.
- +10 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- SafeHeal Inclead
Study Sites (7)
UZA
Antwerp, 2610, Belgium
Centre Hospitalier Universitaire St Pierre
Brussels, 1000, Belgium
CHU Lille
Lille, 59000, France
ICM Montpellier
Montpellier, 34090, France
Hôpital Saint Louis
Paris, 75010, France
Hôpital Saint Antoine Paris
Paris, 75012, France
CHRU Strasbourg
Strasbourg, 67000, France
Related Publications (1)
De Hous N, D'Urso A, Cadiere GB, Cadiere B, Rouanet P, Komen N, Lefevre JH. Evaluation of the SafeHeal Colovac+ anastomosis protection device after low anterior resection for rectal cancer: the safe anastomosis feasibility evaluation (SAFE) 2019 trial. Surg Endosc. 2023 Sep;37(9):7385-7392. doi: 10.1007/s00464-023-10272-x. Epub 2023 Jul 18.
PMID: 37464064DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jérémie Lefevre
Hôpital Saint Antoine Paris
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 26, 2021
First Posted
January 6, 2022
Study Start
December 18, 2019
Primary Completion
February 28, 2022
Study Completion
March 31, 2022
Last Updated
May 1, 2026
Record last verified: 2026-04