Colorectal SurgeryPhase 4COMPRESNCT01091155
COMPRES - COMpression Anastomosis Ring (CAR™ 27/ColonRing™) Post maRketing Evaluation Study
A Phase 4 study testing ColonRing (Colorectal anastomosis) in people with Colorectal Surgery, run by novoGI at 13 sites in 6 countries.
Trial summary
The performance of the ColonRing™ will be comparable to or better than the reported performance of staplers. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Surgery
- What is being tested?
- ColonRing (Colorectal anastomosis)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 288 participants
- Where
- 13 sitesin 6 countries
- Study dates
- Mar 2010to Jul 2011
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 9Show fewer
- Subject has extensive local disease in the pelvis.
- Subject requires more than one anastomosis during the surgery.
- Women who are known to be pregnant.
Trial locations and contacts
13 sites in 6 countries.
13 sites in 6 countries
United States7 sites
NorthShore University Health System
Evanston, Illinois
UCI Medical Center
Irvine, California
University of Southern California Health Sciences Campus
Los Angeles, California
FPMG Center for Colon & Rectal Surgery
Orlando, Florida, 32804
Southern Regional Medical Center
Riverdale, Georgia
Lester E. Cox Medical Center
Springfield, Missouri
St. Louis University Hospital
St Louis, Missouri
Belgium2 sites
Ziekenhuis Oost Limburg
Genk, 3600
University Hospital Gasthuisberg
Leuven, 3000
About this study
The performance of the ColonRing™ will be comparable to or better than the reported performance of staplers.
Read the detailed description
The proposed study is a post marketing study intended to gather and record additional data to further evaluate the performance of the ColonRing™ device in regards to the creation of a colorectal anastomosis.
The study objective is to evaluate the performance of the ColonRing™ in the creation of a circular anastomosis in colorectal procedures.
- Conditions
- Colorectal Surgery
- Being tested
- ColonRing (Colorectal anastomosis)
- Keywords
- Colon Anastomosis, Rectum Anastomosis, Intestine, Colorectal Surgery, Colorectal Anastomosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ColonRing (Colorectal anastomosis)Device
Creation of a colorectal compression anastomosis
| Study group | Role | What they receive |
|---|---|---|
| ColonRing TM | Experimental | Not described Receives: Device: ColonRing (Colorectal anastomosis) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 30 days post op
Secondary outcomes (1)
Rate of Other Device Related Complications and Other Parameters During Hospitalization and Post Procedure.
The post operative parameters that will be measured during hospitalization period:
- 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
- First day to first postoperative flatus
- First day to first postoperative bowel movements
- First day of first postoperative toleration of liquids and solids (time to "keeping them down")
Measured: 30 days post op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2010 (estimated)
- Study startMar 2010
- Primary completionJul 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Colorectal SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 288 participants (actual)
Sponsor and investigators
- Lead sponsor
- novoGI
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Atlanta Colon & Rectal Surgery, Atlanta, GA, FPMG Center for Colon & Rectal Surgery, Lester E. Cox Medical Centers, UCI Medical Center Irvine CA, Endeavor Health, St.Louis University hospital MO, University of Southern California, Bnai Zion Medical Center, Barmherzig Brueder, Catharina Ziekenhuis Eindhoven, Ziekenhuis Oost-Limburg, University Hospital, Gasthuisberg, Klinikum Neuperlach
- Responsible party
- Sponsor
- Investigators
- Eran Choman, Msc, Study director, novoGI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01091155
- Sponsor's protocol ID
- Protocol COMPRES 23/11/2009
- Acronym
- COMPRES
- Status last verified
- Aug 2013
- First submitted
- 19 Mar 2010
- Last updated
- 25 Oct 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COMPRES - COMpression Anastomosis Ring (CAR™ 27/ColonRing™) Post maRketing Evaluation Study
- ClinicalTrials.gov ID
- NCT01091155
- Acronym / sponsor ID
- COMPRES / Protocol COMPRES 23/11/2009
- Conditions
- Colorectal Surgery
- Keywords
- Colon Anastomosis, Rectum Anastomosis, Intestine, Colorectal Surgery, Colorectal Anastomosis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 288 participants (actual)
- Lead sponsor
- novoGIIndustry (pharma, biotech, devices)
- Collaborators
- Atlanta Colon & Rectal Surgery, Atlanta, GA, FPMG Center for Colon & Rectal Surgery, Lester E. Cox Medical Centers, UCI Medical Center Irvine CA, Endeavor Health, St.Louis University hospital MO, University of Southern California, Bnai Zion Medical Center, Barmherzig Brueder, Catharina Ziekenhuis Eindhoven, Ziekenhuis Oost-Limburg, University Hospital, Gasthuisberg, Klinikum Neuperlach
- Study start
- Mar 2010
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 23 Mar 2010 (estimated)
- Results
- Posted 25 Oct 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The performance of the ColonRing™ will be comparable to or better than the reported performance of staplers.
Detailed description
The proposed study is a post marketing study intended to gather and record additional data to further evaluate the performance of the ColonRing™ device in regards to the creation of a colorectal anastomosis.
The study objective is to evaluate the performance of the ColonRing™ in the creation of a circular anastomosis in colorectal procedures.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ColonRing TM | Experimental | Device: ColonRing (Colorectal anastomosis) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ColonRing (Colorectal anastomosis)Creation of a colorectal compression anastomosis | Device | ColonRing TM |
Primary outcome
To Evaluate Rate of Anastomotic Leaks Related to the Use of the ColonRing™ Device, at 1 Month
Time frame: 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.
Device Related Leak Rate up to 30 Days Post op
Time frame: 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.
1 secondary outcome
Rate of Other Device Related Complications and Other Parameters During Hospitalization and Post Procedure.
Time frame: 30 days post op
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Click here for more information about study device (sponsor's web site)Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eran Choman, Msc study director
novoGI
13 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing ColonRing (Colorectal anastomosis) in people with Colorectal Surgery, run by novoGI at 13 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States, Belgium, Austria, Germany, Israel and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Oct 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To Evaluate Rate of Anastomotic Leaks Related to the Use of the ColonRing™ Device, at 1 Month (time frame: Approx. 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2013.