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Trial Outcomes & Findings for COMPRES - COMpression Anastomosis Ring (CAR™ 27/ColonRing™) Post maRketing Evaluation Study (NCT NCT01091155)

NCT ID: NCT01091155

Last Updated: 2013-10-25

Results Overview

Anastomotic leakage will be defined as clinical symptoms such as fever or sepsis in combination with pelvic abscess, rectovaginal fistula or peritonitis within 30 days postoperatively leading to a clinical and / or radiological interventional procedure of the subject, or operation that confirms the leakage which has been determined to be related to the device.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

288 participants

Primary outcome timeframe

Approx. 1 year

Results posted on

2013-10-25

Participant Flow

Participant milestones

Participant milestones
Measure
ColonRing TM
ColonRing (Colorectal anastomosis) : Creation of a colorectal compression anastomosis
Overall Study
STARTED
288
Overall Study
COMPLETED
279
Overall Study
NOT COMPLETED
9

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

COMPRES - COMpression Anastomosis Ring (CAR™ 27/ColonRing™) Post maRketing Evaluation Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
ColonRing TM
n=288 Participants
ColonRing (Colorectal anastomosis) : Creation of a colorectal compression anastomosis
Age, Categorical
<=18 years
0 Participants
n=5 Participants
Age, Categorical
Between 18 and 65 years
177 Participants
n=5 Participants
Age, Categorical
>=65 years
111 Participants
n=5 Participants
Age Continuous
60 years
STANDARD_DEVIATION 13.4 • n=5 Participants
Sex: Female, Male
Female
146 Participants
n=5 Participants
Sex: Female, Male
Male
142 Participants
n=5 Participants
Region of Enrollment
United States
127 participants
n=5 Participants
Region of Enrollment
Belgium
83 participants
n=5 Participants
Region of Enrollment
Austria
46 participants
n=5 Participants
Region of Enrollment
Israel
13 participants
n=5 Participants
Region of Enrollment
Germany
9 participants
n=5 Participants
Region of Enrollment
Netherlands
10 participants
n=5 Participants

PRIMARY outcome

Timeframe: Approx. 1 year

Anastomotic leakage will be defined as clinical symptoms such as fever or sepsis in combination with pelvic abscess, rectovaginal fistula or peritonitis within 30 days postoperatively leading to a clinical and / or radiological interventional procedure of the subject, or operation that confirms the leakage which has been determined to be related to the device.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 30 days post op

Anastomotic leakage will be defined as clinical symptoms such as fever or sepsis in combination with pelvic abscess, rectovaginal fistula or peritonitis within 30 days postoperatively leading to a clinical and / or radiological interventional procedure of the subject, or operation that confirms the leakage which has been determined to be related to the device.

Outcome measures

Outcome measures
Measure
ColonRing TM
n=279 Participants
ColonRing (Colorectal anastomosis) : Creation of a colorectal compression anastomosis
Device Related Leak Rate up to 30 Days Post op
4 participants

SECONDARY outcome

Timeframe: 30 days post op

The post operative parameters that will be measured during hospitalization period: 1. Hospitalization time (two dates will be recorded: ready for discharge and discharge). The later noting where the subject was discharged to - e.g. nursing home or home 2. First day to first postoperative flatus 3. First day to first postoperative bowel movements 4. First day of first postoperative toleration of liquids and solids (time to "keeping them down")

Outcome measures

Outcome data not reported

Adverse Events

ColonRing TM

Serious events: 26 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure
ColonRing TM
n=279 participants at risk
ColonRing (Colorectal anastomosis) : Creation of a colorectal compression anastomosis
Surgical and medical procedures
Leak
5.7%
16/279 • Number of events 26
Surgical and medical procedures
Abscess
2.9%
8/279 • Number of events 26
Surgical and medical procedures
Fistula
0.72%
2/279 • Number of events 26

Other adverse events

Adverse event data not reported

Additional Information

Eran Choman, VP Clinical Affairs & Statistics

novoGI

Phone: +972 9 8603000

Results disclosure agreements

  • Principal investigator is a sponsor employee 14.1 Review. Institution may publish the results of the Study, based on information collected or generated by Institution and Principal Investigator within the framework thereof, subject to the provisions of this section. In any event, however, no publication, presentation in any forum or any other form of disclosure with respect to the Study or the results thereof will be made prior to the publication of the Joint Publication without Sponsor's prior written consent.
  • Publication restrictions are in place

Restriction type: OTHER