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Completed

NCT Number: NCT01091155

COMPRES - COMpression Anastomosis Ring (CAR™ 27/ColonRing™) Post maRketing Evaluation Study

The performance of the ColonRing™ will be comparable to or better than the reported performance of staplers.

Completed

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Key information

Conditions

Colorectal Surgery

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

KH Barmherzig Brueder, Vienna, Austria

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About this study

The proposed study is a post marketing study intended to gather and record additional data to further evaluate the performance of the ColonRing™ device in regards to the creation of a colorectal anastomosis.

The study objective is to evaluate the performance of the ColonRing™ in the creation of a circular anastomosis in colorectal procedures.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Subject is ≥ 18 years old.
  • BMI < 34.
  • Subject is planned to undergo a non-emergency (i.e., elective) operation with the creation of an anastomosis using the ColonRing™.
  • Subject signs and dates a written informed consent form (ICF) and indicates an understanding of the study procedures.

Exclusion criteria

  • Subject has a known allergy to nickel.
  • Subject is planned to undergo an emergency procedure or has a diagnosis of bowel strangulation, peritonitis, bowel perforation, local or systemic infection, ischemic bowel,carcinomatosis.
  • Subject has participated in another clinical study which may affect this study's outcomes within the last 30 days.
  • Subject's ASA (American Society of Anesthesiology) score 4 or 5.
  • Subject has a concurrent or previous invasive pelvic malignancy.
  • Subject has a systemic or incapacitating disease.
  • Subject has extensive local disease in the pelvis.
  • Subject requires more than one anastomosis during the surgery.
  • Women who are known to be pregnant.

Treatment and study plan

ColonRing (Colorectal anastomosis)

Device

Creation of a colorectal compression anastomosis

Primary outcomes

  1. To Evaluate Rate of Anastomotic Leaks Related to the Use of the ColonRing™ Device, at 1 Month

    Time frame: Approx. 1 year

    Anastomotic leakage will be defined as clinical symptoms such as fever or sepsis in combination with pelvic abscess, rectovaginal fistula or peritonitis within 30 days postoperatively leading to a clinical and / or radiological interventional procedure of the subject, or operation that confirms the leakage which has been determined to be related to the device.

  2. Device Related Leak Rate up to 30 Days Post op

    Time frame: 30 days post op

    Anastomotic leakage will be defined as clinical symptoms such as fever or sepsis in combination with pelvic abscess, rectovaginal fistula or peritonitis within 30 days postoperatively leading to a clinical and / or radiological interventional procedure of the subject, or operation that confirms the leakage which has been determined to be related to the device.

Secondary outcomes

  1. Rate of Other Device Related Complications and Other Parameters During Hospitalization and Post Procedure.

    Time frame: 30 days post op

    The post operative parameters that will be measured during hospitalization period:

    • Hospitalization time (two dates will be recorded: ready for discharge and discharge). The later noting where the subject was discharged to - e.g. nursing home or home
    • First day to first postoperative flatus
    • First day to first postoperative bowel movements
    • First day of first postoperative toleration of liquids and solids (time to "keeping them down")

Sponsors and collaborators

Lead sponsor

novoGI

Industry

Collaborators

  • Atlanta Colon & Rectal Surgery, Atlanta, GA
  • Barmherzig Brueder
  • Bnai Zion Medical Center
  • Catharina Ziekenhuis Eindhoven
  • Endeavor Health
  • FPMG Center for Colon & Rectal Surgery
  • Klinikum Neuperlach
  • Lester E. Cox Medical Centers
  • St.Louis University hospital MO
  • UCI Medical Center Irvine CA
  • University Hospital, Gasthuisberg
  • University of Southern California
  • Ziekenhuis Oost-Limburg

Registry information

Acronym: COMPRES

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Mar 23, 2010
Registry last updated
Oct 25, 2013

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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