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

novoGI

Status: Completed

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

Treatments: Device: ColonRing™

Study type: Observational

Funder types: Industry

Identifiers

NCT01301417

RETROPRESS

Details and patient eligibility

About

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.

Enrollment: 171 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

171 participants in 1 patient group

ColonRing™

Description:

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

Treatment:

Device: ColonRing™