A RETROspective Data Collection of comPRESSion Anastomosis Using the ColonRing

NCT ID: NCT01880918

Last Updated: 2013-06-19

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

UNKNOWN

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-10-31

Study Completion Date

2013-07-31

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 4-6 centers. The data will assist in future evaluating the performance of the ColonRing device in regards to the creation of a colorectal anastomosis in Low Anterior Resection procedures.

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

The ColonRing device is intended to be used for the creation of intestinal anastomoses in colorectal surgery in both open and laparoscopic surgeries. This indication is within the currently cleared indication of the ColonRing device, which has been cleared by the US FDA and carries the CE Mark for use throughout the alimentary trct for the creation of circular end-to-end, side-to-end or side-to-side anastomosis.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

1. Patient was \> 18 years old at time of procedure
2. Patient underwent a technically successful open or laparoscopic colorectal, Low Anterior Resection procedure with the creation of an anastomosis using the ColonRing™
3. Patient treated in routine clinical practice
4. 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

Locations

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Florida Hospital, Center for Colon & Rectal Surgery

Atlamonte Springs, Florida, United States

Site Status RECRUITING

18308 Murdock Circle, Suite 108

Port Charlotte, Florida, United States

Site Status RECRUITING

CoxHealth Hospital, Colorectal Department

Springfield, Missouri, United States

Site Status RECRUITING

Countries

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United States

Facility Contacts

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Dr. Matthew Albert, MD

Role: primary

407-303-5191

Leslee Cunnion

Role: backup

407-303-5191

Dr. Domingo E. Galliano Jr., MD

Role: primary

941-625-3411

Kathleen Lueck

Role: backup

Dr. Jose Dominguez, MD

Role: primary

417-875-3211

Kami Oster

Role: backup

417- 875-3211

Other Identifiers

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RETROPRESS, CLPR-43-11-01

Identifier Type: -

Identifier Source: org_study_id

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