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Data Collection of Patients Treated With the ColonRing™ for the Creation of Circular Compression Anastomosis (RETROPRESS)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2011 by novoGI.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
novoGI
ClinicalTrials.gov Identifier:
NCT01301417
First received: February 20, 2011
Last updated: February 22, 2011
Last verified: February 2011
History of Changes
  Purpose

The proposed study is a post marketing, observational, retrospective data collection intended to gather and record data on patients treated with the ColonRing™ device in routine clinical practice at a single center. The data will assist in further evaluating the performance of the ColonRing™ device in regards to the creation of a colorectal anastomosis.

Hypothesis:The performance of the ColonRing™, determined by the rate of complications, will be within the acceptable range reported in the literature for alternative treatment modalities.


Condition Intervention
Diverticulum, Colon
Colorectal Neoplasms
Crohn Disease
Colitis, Ulcerative
Colostomy
Ileostomy - Stoma
Rectal Prolapse
Intestinal Polyposis
Lymphoma
Endometriosis
Intestinal Volvulus
 Device: ColonRing™

Study Type: Observational
Study Design: Time Perspective: Retrospective
Official Title: a RETROspective Data Collection of comPRESSion Anastomosis Using the ColonRing ™

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by novoGI:

Primary Outcome Measures:
  • Rate of anastomotic leakage [ Time Frame: 2-mo post-op ] [ Designated as safety issue: Yes ]
    The primary study outcome is the rate of anastomotic leakage. Anastomotic leakage is defined as evidence of a defect in the intestinal wall integrity at the anastomotic site leading to a communication between the intra and extra luminal compartments.


Secondary Outcome Measures:
  • Rate of other device related complications and measures during hospitalization and post procedure: [ Time Frame: 2-mo post-op ] [ Designated as safety issue: Yes ]

    The following complications will be examined for relation to the device:

    Bleeding. Stricture (either clinical evidence of a stricture or the inability to pass a 12 mm sigmoidoscope through the anastomosis in a procedure that does not include a diversion). Septic complication (including wound infection, pelvic infection, peritonitis, abscess).

    Readmission, re-operation, death within two months of the procedure. Extra colonic complications (including urinary infection, urinary retention, DVT, pneumonitis, pulmonary embolism, cardiac, injury to other organs - e.g. spleen, ureter)



Estimated Enrollment: 200
Study Start Date: February 2011
Groups/Cohorts Assigned Interventions
ColonRing™
Adult Patients who underwent a laparoscopic or open colorectal resection with the creation of an anastomosis using the ColonRing™ in routine clinical practice
 Device: ColonRing™
Creation of a circular Compression Anastomosis
Other Name: Compression Anaqstomosis Ring™(CAR™)27

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Adult Patients who underwent a laparoscopic or open colorectal resection with the creation of an anastomosis using the ColonRing™ in routine clinical practice.

Criteria

Inclusion Criteria:

  • Patient was > 18 years old at time of procedure
  • Patient underwent an open or laparoscopic colorectal procedure with the creation of an anastomosis using the ColonRing™
  • Patient treated in routine clinical practice following marketing clearance of the device within the cleared intended use
  • Patient underwent his/her first follow-up visit within two months post-surgery

Exclusion Criteria:

  • No exclusion criteria have been defined for this data collection.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01301417

Locations
United States, Georgia
Southern Regional Medical Center Recruiting
Riverdale, Georgia, United States, 30274
Contact: Stephen Cohen, MD     770-997-1975     stephencohen615@gmail.com    
Contact: Susan Honea     770-9971975     shonea@atlantacolon.com    
Principal Investigator: Stephen Cohen, MD            
Sponsors and Collaborators
novoGI
Investigators
Study Director: Yael Nir, MD NiTi Surgical Solutions Ltd.
  More Information

No publications provided

Responsible Party: Dr. Yael Nir, NiTi surgical Solutions
ClinicalTrials.gov Identifier: NCT01301417     History of Changes
Other Study ID Numbers: RETROPRESS
Study First Received: February 20, 2011
Last Updated: February 22, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by novoGI:
Compression Anastomosis

Additional relevant MeSH terms:
Neoplasms
Colitis
Colitis, Ulcerative
Colorectal Neoplasms
Crohn Disease
Diverticulum, Colon
Diverticulum
Endometriosis
Lymphoma
Prolapse
Rectal Prolapse
Ulcer
Intestinal Volvulus
Intestinal Polyposis
Gastroenteritis
 Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Inflammatory Bowel Diseases
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Rectal Diseases
Pathological Conditions, Anatomical
Genital Diseases, Female
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases

ClinicalTrials.gov processed this record on May 16, 2013