COLOVAC
DeviceThe 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.
NCT Number: NCT03352570
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).
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Notify Me18 year–65 year
All sexes
Interventional
Not applicable
UZA Antwerp, Antwerp, Belgium
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: up to 3 months
occurence of intraoperative and postoperative complications
Time frame: During surgery
Ability to introduce, deploy and retrieve the Colovac Anastomosis Protection Device in/from the desired location in the colon
Time frame: During surgery
Measured by number of successful placement divided by overall placement number
Time frame: During surgery
Procedure duration measured in minutes
Time frame: During surgical procedure and up to 15 days after placement
defined by the number of devices migrated over the anastomosis divided by the number of devices placed
Time frame: At 14 days after device placement
Retrieval success rate measured by number of successful retrieval without complication divided by overall number of retrieval performed
Time frame: up to 15 days after surgery
Measured as number of patients presenting digestive disorders divided by overall number of patients
Time frame: up to 15 days after surgery
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 3 months after initial surgery
measured as mean number of anastomosis leakage episodes per patient
Time frame: up to 3 months after initial surgery
measured as mean number of anastomosis fisutal episodes per patient
Time frame: up to 3 months after initial surgery
measured as mean number of anastomosis abcess episodes per patient
Safeheal
Industry
Safe (Safe Anastomosis Feasibility Evaluation)-1 Study : a Study to Investigate the Efficacy, Mechanism of Action and Safety of the Colovac Colorectal Anastomosis Protection Device First-In-man Clinical Investigation Study
Acronym: SAFE-1
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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