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

NCT ID: NCT01301417

Last Updated: 2013-06-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

171 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-02-28

Study Completion Date

2011-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Diverticulum, Colon Colorectal Neoplasms Crohn Disease Colitis, Ulcerative Colostomy Ileostomy - Stoma Rectal Prolapse Intestinal Polyposis Lymphoma Endometriosis Intestinal Volvulus

Study Design

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Study Time Perspective

RETROSPECTIVE

Study Groups

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ColonRing™

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

ColonRing™

Intervention Type DEVICE

Creation of a circular Compression Anastomosis

Interventions

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ColonRing™

Creation of a circular Compression Anastomosis

Intervention Type DEVICE

Other Intervention Names

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Compression Anaqstomosis Ring™(CAR™)27

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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novoGI

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Eran Choman, Msc

Role: STUDY_DIRECTOR

novoGI

Locations

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Southern Regional Medical Center

Riverdale, Georgia, United States

Site Status

Countries

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United States

Other Identifiers

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RETROPRESS

Identifier Type: -

Identifier Source: org_study_id

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