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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| COLOVAC device | Experimental | colorectal surgery performed per standard of care with deployment of the Colovac device to protect the anastomosis site |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| COLOVAC | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of adverse events | occurence of intraoperative and postoperative complications | up to 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| device introduction success rate | Ability to introduce, deploy and retrieve the Colovac Anastomosis Protection Device in/from the desired location in the colon | During surgery |
| Device placement success rate |
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Inclusion Criteria:
Exclusion Criteria:
Patient with inflammatory bowel disease
Pregnant or nursing female subject (a pregnancy test should be conducted the day prior to the procedure for all women in age of procreating)
Known allergy to nickel or other components of the Colovac kit
Any significant medical condition which, in the investigator's opinion, may interfere with the subject's optimal participation in the study, including:
The subject is currently participating in another investigational drug or device study that has not completed the primary endpoint or that clinically interferes with the endpoints of this study
Patient unable to give consent
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UZA Antwerp | Antwerp | 2650 | Belgium | |||
| Hopital Saint-Antoine |
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| ID | Term |
|---|---|
| D057868 | Anastomotic Leak |
| D005402 | Fistula |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020763 | Pathological Conditions, Anatomical |
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Measured by number of successful placement divided by overall placement number
| During surgery |
| Colovac procedure time | Procedure duration measured in minutes | 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 | 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 | At 14 days after device placement |
| rate of digestive disorders | Measured as number of patients presenting digestive disorders divided by overall number of patients | 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) | up to 15 days after surgery |
| occurence of anastomosis leakage | measured as mean number of anastomosis leakage episodes per patient | up to 3 months after initial surgery |
| occurrence of anastomosis fistula | measured as mean number of anastomosis fisutal episodes per patient | up to 3 months after initial surgery |
| occurrence of anastomotic abcesses | measured as mean number of anastomosis abcess episodes per patient | up to 3 months after initial surgery |
| Paris |
| 75012 |
| France |
| Ihu Strasbourg | Strasbourg | 67091 | France |