NCT01091155

Brief Summary

The performance of the ColonRing™ will be comparable to or better than the reported performance of staplers.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
288

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Mar 2010

Geographic Reach
6 countries

13 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2010

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

March 19, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 23, 2010

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
2.3 years until next milestone

Results Posted

Study results publicly available

October 25, 2013

Completed
Last Updated

October 25, 2013

Status Verified

August 1, 2013

Enrollment Period

1.3 years

First QC Date

March 19, 2010

Results QC Date

June 4, 2013

Last Update Submit

August 20, 2013

Conditions

Colorectal Surgery

Keywords

Colon AnastomosisRectum AnastomosisIntestineColorectal SurgeryColorectal Anastomosis

Outcome Measures

Primary Outcomes (2)

  • To Evaluate Rate of Anastomotic Leaks Related to the Use of the ColonRing™ Device, at 1 Month

    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.

    Approx. 1 year

  • Device Related Leak Rate up to 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.

    30 days post op

Secondary Outcomes (1)

  • Rate of Other Device Related Complications and Other Parameters During Hospitalization and Post Procedure.

    30 days post op

Study Arms (1)

ColonRing TM

EXPERIMENTAL
Device: ColonRing (Colorectal anastomosis)

Interventions

ColonRing (Colorectal anastomosis)DEVICE

Creation of a colorectal compression anastomosis

ColonRing TM

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subject is ≥ 18 years old.
  • BMI \< 34.
  • Subject is planned to undergo a non-emergency (i.e., elective) operation with the creation of an anastomosis using the ColonRing™.
  • Subject signs and dates a written informed consent form (ICF) and indicates an understanding of the study procedures.

You may not qualify if:

  • Subject has a known allergy to nickel.
  • Subject is planned to undergo an emergency procedure or has a diagnosis of bowel strangulation, peritonitis, bowel perforation, local or systemic infection, ischemic bowel,carcinomatosis.
  • Subject has participated in another clinical study which may affect this study's outcomes within the last 30 days.
  • Subject's ASA (American Society of Anesthesiology) score 4 or 5.
  • Subject has a concurrent or previous invasive pelvic malignancy.
  • Subject has a systemic or incapacitating disease.
  • Subject has extensive local disease in the pelvis.
  • Subject requires more than one anastomosis during the surgery.
  • Women who are known to be pregnant.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

UCI Medical Center

Irvine, California, United States

Location

University of Southern California Health Sciences Campus

Los Angeles, California, United States

Location

FPMG Center for Colon & Rectal Surgery

Orlando, Florida, 32804, United States

Location

Southern Regional Medical Center

Riverdale, Georgia, United States

Location

NorthShore University Health System

Evanston, Illinois, United States

Location

Lester E. Cox Medical Center

Springfield, Missouri, United States

Location

St. Louis University Hospital

St Louis, Missouri, United States

Location

KH Barmherzig Brueder

Vienna, A-1020, Austria

Location

Ziekenhuis Oost Limburg

Genk, 3600, Belgium

Location

University Hospital Gasthuisberg

Leuven, 3000, Belgium

Location

Klinikum Neuperlach

Munich, 81737, Germany

Location

Bnai Zion Medical Center

Haifa, 31048, Israel

Location

Catharina Ziekenhuis

Eindhoven, 5623EJ, Netherlands

Location

Related Links

Limitations and Caveats

The study had acceptable rate of AE, and technical problems.

Results Point of Contact

Title
Eran Choman, VP Clinical Affairs & Statistics
Organization
novoGI
eran.choman@novogi.com
+972 9 8603000

Study Officials

  • Eran Choman, Msc

    novoGI

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 19, 2010

First Posted

March 23, 2010

Study Start

March 1, 2010

Primary Completion

July 1, 2011

Study Completion

July 1, 2011

Last Updated

October 25, 2013

Results First Posted

October 25, 2013

Record last verified: 2013-08

Locations

AU(1)NL(1)DE(1)IL(1)BE(2)US(7)