Diverticulum, ColonRETROPRESSNCT01301417
Data Collection of Patients Treated With the ColonRing™ for the Creation of Circular Compression Anastomosis
An observational study of Diverticulum, Colon and Colorectal Neoplasms, run by novoGI at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diverticulum, Colon, Colorectal Neoplasms, Crohn Disease
- What is being tested?
- ColonRing™
- Type of treatment
- Medical device
- How many people
- 171 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2011to Aug 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
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
Study population: Adult Patients who underwent a laparoscopic or open colorectal resection with the creation of an anastomosis using the ColonRing™ in routine clinical practice.
Who may be able to join
- 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
Who cannot join
- No exclusion criteria have been defined for this data collection.
Trial locations and contacts
1 site in 1 country.
United States1 site
Southern Regional Medical Center
Riverdale, Georgia, 30274
About this study
Official title: a RETROspective Data Collection of comPRESSion Anastomosis Using the ColonRing ™
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.
- Conditions
- Diverticulum, Colon, Colorectal Neoplasms, Crohn Disease, Colitis, Ulcerative, Colostomy, Ileostomy - Stoma
- Being tested
- ColonRing™
- Keywords
- Compression Anastomosis
- Medical subject headings
- Diverticulum, Colon, Colorectal Neoplasms, Crohn Disease, Colitis, Ulcerative, Rectal Prolapse, Intestinal Polyposis, Lymphoma, Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ColonRing™Device
Also called Compression Anaqstomosis Ring™(CAR™)27
Creation of a circular Compression Anastomosis
| Study group | Role | What they receive |
|---|---|---|
| ColonRing™ | Adult Patients who underwent a laparoscopic or open colorectal resection with the creation of an anastomosis using the ColonRing™ in routine clinical practice Receives: Device: ColonRing™ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of anastomotic leakage
The primary study outcome is the rate of anastomotic leakage. Anastomotic leakage is defined as evidence of a defect in the intestinal wall integrity at the anastomotic site leading to a communication between the intra and extra luminal compartments.
Measured: 2-mo post-op
Secondary outcomes (1)
Rate of other device related complications and measures during hospitalization and post procedure:
The following complications will be examined for relation to the device:
Bleeding. Stricture (either clinical evidence of a stricture or the inability to pass a 12 mm sigmoidoscope through the anastomosis in a procedure that does not include a diversion). Septic complication (including wound infection, pelvic infection, peritonitis, abscess).
Readmission, re-operation, death within two months of the procedure. Extra colonic complications (including urinary infection, urinary retention, DVT, pneumonitis, pulmonary embolism, cardiac, injury to other organs - e.g. spleen, ureter)
Measured: 2-mo 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 Feb 2011 (estimated)
- Study startFeb 2011
- Primary completionAug 2011
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diverticulum, ColonStudies 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
- Observational
- Time perspective
- Retrospective
- Enrolment
- 171 participants (actual)
Sponsor and investigators
- Lead sponsor
- novoGI
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Eran Choman, Msc, Study director, novoGI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01301417
- Sponsor's protocol ID
- RETROPRESS
- Acronym
- RETROPRESS
- Status last verified
- Jun 2013
- First submitted
- 20 Feb 2011
- Last updated
- 5 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- a RETROspective Data Collection of comPRESSion Anastomosis Using the ColonRing ™
- ClinicalTrials.gov ID
- NCT01301417
- Acronym / sponsor ID
- RETROPRESS / RETROPRESS
- Conditions
- Diverticulum, Colon, Colorectal Neoplasms, Crohn Disease, Colitis, Ulcerative, Colostomy, Ileostomy - Stoma
- Keywords
- Compression Anastomosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 171 participants (actual)
- Lead sponsor
- novoGIIndustry (pharma, biotech, devices)
- Study start
- Feb 2011
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 23 Feb 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ColonRing™ | – | Device: ColonRing™Adult Patients who underwent a laparoscopic or open colorectal resection with the creation of an anastomosis using the ColonRing™ in routine clinical practice |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult Patients who underwent a laparoscopic or open colorectal resection with the creation of an anastomosis using the ColonRing™ in routine clinical practice.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- No exclusion criteria have been defined for this data collection.
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™Also: Compression Anaqstomosis Ring™(CAR™)27Creation of a circular Compression Anastomosis | Device | ColonRing™ |
Primary outcome
Rate of anastomotic leakage
Time frame: 2-mo post-op
The primary study outcome is the rate of anastomotic leakage. Anastomotic leakage is defined as evidence of a defect in the intestinal wall integrity at the anastomotic site leading to a communication between the intra and extra luminal compartments.
1 secondary outcome
Rate of other device related complications and measures during hospitalization and post procedure:
Time frame: 2-mo post-op
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2013.
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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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diverticulum, Colon and Colorectal Neoplasms, run by novoGI at 1 site in United States.
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 1 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 5 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Rate of anastomotic leakage (time frame: 2-mo post-op). 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 5 Jun 2013.