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OpenTrials
Completed

NCT Number: NCT03352570

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

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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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UZA Antwerp, Antwerp, Belgium

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subject must be >= 18 and <= 65 years old
  • Indicated for colorectal resection
  • Patient has been assessed by a multi-disciplinary team and it was determined that as per standard of care, they are eligible to bear a diverting ostomy
  • Willing to comply with protocol-specified follow-up evaluations
  • Signed Informed Consent

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:
  • immunodeficiency
  • steroid therapy
  • infections at the time of intervention
  • 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, local or systemic infection, ischemic bowel, carcinomatosis
  • preexisting sphincter problems or evidence of extensive local disease in the pelvis
  • blood loss (> 500 cc)
  • non amended peroperative anastomosis failure
  • intra-operative adverse events
  • malnourishment
  • obesity (BMI > 35)
  • history of excessive smoking and alcohol use
  • 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

Treatment and study plan

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.

Primary outcomes

  1. Rate of adverse events

    Time frame: up to 3 months

    occurence of intraoperative and postoperative complications

Secondary outcomes

  1. device introduction success rate

    Time frame: During surgery

    Ability to introduce, deploy and retrieve the Colovac Anastomosis Protection Device in/from the desired location in the colon

  2. Device placement success rate

    Time frame: During surgery

    Measured by number of successful placement divided by overall placement number

  3. Colovac procedure time

    Time frame: During surgery

    Procedure duration measured in minutes

  4. Migration rate of the Colovac device

    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

  5. Device retrieval success rate

    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

  6. rate of digestive disorders

    Time frame: up to 15 days after surgery

    Measured as number of patients presenting digestive disorders divided by overall number of patients

  7. level of patient comfort measured using NIH's PROMIS health measurement questionnaires

    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)

  8. occurence of anastomosis leakage

    Time frame: up to 3 months after initial surgery

    measured as mean number of anastomosis leakage episodes per patient

  9. occurrence of anastomosis fistula

    Time frame: up to 3 months after initial surgery

    measured as mean number of anastomosis fisutal episodes per patient

  10. occurrence of anastomotic abcesses

    Time frame: up to 3 months after initial surgery

    measured as mean number of anastomosis abcess episodes per patient

Sponsors and collaborators

Lead sponsor

Safeheal

Industry

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2019
First posted
Nov 24, 2017
Registry last updated
Oct 10, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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