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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
novoGI
ClinicalTrials.gov Identifier:
NCT01301417
First received: February 20, 2011
Last updated: June 4, 2013
Last verified: June 2013
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)
Enrollment: 171
Study Start Date: February 2011
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
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   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01301417

Locations
United States, Georgia
Southern Regional Medical Center
Riverdale, Georgia, United States, 30274
Sponsors and Collaborators
novoGI
Investigators
Study Director: Eran Choman, Msc novoGI
  More Information

Responsible Party: novoGI
ClinicalTrials.gov Identifier: NCT01301417     History of Changes
Other Study ID Numbers: RETROPRESS 
Study First Received: February 20, 2011
Last Updated: June 4, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by novoGI:
Compression Anastomosis

Additional relevant MeSH terms:
Crohn Disease
Colitis
Prolapse
Endometriosis
Colorectal Neoplasms
Colitis, Ulcerative
Rectal Prolapse
Diverticulum
Intestinal Polyposis
Intestinal Volvulus
Diverticulum, Colon
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
 Digestive System Diseases
Intestinal Diseases
Colonic Diseases
Pathological Conditions, Anatomical
Genital Diseases, Female
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Rectal Diseases
Pelvic Organ Prolapse
Intestinal Obstruction
Torsion Abnormality

ClinicalTrials.gov processed this record on September 26, 2016