An interventional study of COLOVAC in Gastrointestinal Anastomotic Complication, sponsored by Safeheal. Completed at 3 sites in 2 countries. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2019-10-10.
Sponsored by Safeheal · Not applicable, Interventional, and Device feasibility
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Among 12 studies in Anastomotic Leak with a site in France — 5 open to participants now, 5 under way, 1 of them phase 3. Anastomotic Leak · France.
Among the 12 studies in Anastomotic Leak with a site in France, this one is the only one that started in 2017, is one of 3 with no phase, and was the 3rd registered.
240 studies on the registry are indexed under Anastomotic Leak; 72 are open to participants now.
Browse Anastomotic Leak studies →5 of the 12 studies in Anastomotic Leak with a site in France are open now. Recruiting first, the newest first:
Centre Hospitalier Universitaire, Amiens · Sites in France
Ages 18+
Amsterdam UMC, location VUmc · Sites in France, Italy, Netherlands and 2 more countries
Ages 18+
Centre Hospitalier Universitaire de Besancon · Sites in France
Ages 18+
Bordeaux Colorectal Institute · Sites in France, Belgium, Canada and 3 more countries
Ages 18+
Centre Hospitalier Universitaire de Saint Etienne · Sites in France
Ages 18+
A study can be open while its sites in France have not opened yet or have stopped. Only those recruiting at a site in France →
Of the 45 Anastomotic Leak studies recruiting now, 23 (51%) set no upper age limit and 11 (24%) stop at 75 or younger; 1 takes children under 18; 1 takes healthy volunteers.
This study: 18 Years to 65 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
12 studies; the count open now beside each. This study's row is marked.
First in 2007; this study’s year is marked. 1 started in 2017.
This study's enrollment of 15 is below the median of 140 across 128 interventional studies indexed under Anastomotic Leak.
Median enrollment 186 across the 5 interventional studies, 120 across the 7 observational. Of the 6 that completed or were terminated, 0 (0%) have results posted.
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1 of 12 have an industry lead sponsor. The 10 most frequent:
Safeheal is the lead sponsor of 2 studies on the registry; none are open to participants now.
Safeheal has 1 study filed under Anastomotic Leak — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 12 studies in Anastomotic Leak with a site in France, from their registry updates:
Nothing recorded among them since 2026-09-25.
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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).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Any significant medical condition which, in the investigator's opinion, may interfere with the subject's optimal participation in the study, including:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
colorectal surgery performed per standard of care with deployment of the Colovac device to protect the anastomosis site
Device: COLOVAC
The intervention consists in the placement of the Colovac device, during the colorectal surgery, Once the colorectal anastomosis has been completed as per standard care and the water-thightness of the anastomosis has been verified.
Rate of adverse events
occurence of intraoperative and postoperative complications
Time frame: up to 3 months
device introduction success rate
Ability to introduce, deploy and retrieve the Colovac Anastomosis Protection Device in/from the desired location in the colon
Time frame: During surgery
Device placement success rate
Measured by number of successful placement divided by overall placement number
Time frame: During surgery
Colovac procedure time
Procedure duration measured in minutes
Time frame: During surgery
Migration rate of the Colovac device
defined by the number of devices migrated over the anastomosis divided by the number of devices placed
Time frame: During surgical procedure and up to 15 days after placement
Device retrieval success rate
Retrieval success rate measured by number of successful retrieval without complication divided by overall number of retrieval performed
Time frame: At 14 days after device placement
rate of digestive disorders
Measured as number of patients presenting digestive disorders divided by overall number of patients
Time frame: up to 15 days after surgery
level of patient comfort measured using NIH's PROMIS health measurement questionnaires
measures using health measurement questionnaires to assess parameters like pain (visual analogue scale - 1 : no pain - 10 : worse pain ever); bowel incontinence (visual analogue scale - 1 : no incontinence - 10 : uncontrollable incontinence), diarrhea (visual analogue scale - 1 : no pain - 10 : worse pain ever); bowel incontinence (visual analogue scale - 1 : no diarrhea - 10 : more than 3 episodes of diarrhea per day)
Time frame: up to 15 days after surgery
occurence of anastomosis leakage
measured as mean number of anastomosis leakage episodes per patient
Time frame: up to 3 months after initial surgery
occurrence of anastomosis fistula
measured as mean number of anastomosis fisutal episodes per patient
Time frame: up to 3 months after initial surgery
occurrence of anastomotic abcesses
measured as mean number of anastomosis abcess episodes per patient
Time frame: up to 3 months after initial surgery
Plan to share: Undecided
No publications or documents are linked to this record.
Ran from Nov 2017 to primary completion in Sep 2018, 10 months.
Of 65 interventional studies with no phase under Anastomotic Leak, half reached primary completion within 32 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 42. This study's 10 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.
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Safeheal