Colonic ObstructionNCT01102283
Treatment of Colonic Obstruction With Cook Evolution® Colonic Stent System
An observational study of Colonic Obstruction and Colonic Stricture, run by Cook Group Incorporated at 10 sites in 7 countries.
Trial summary
The objective of this registry is to compile clinical data on the use of the Evolution® Colonic Stent System for the palliative treatment of colonic obstruction or strictures caused by malignant neoplasms and to relieve acute large bowel obstruction prior to colectomy in patients with malignant strictures. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colonic Obstruction, Colonic Stricture, Large Bowel Obstruction
- What is being tested?
- Evolution(R) Colonic Stent
- Type of treatment
- Medical device
- How many people
- 80 participants
- Where
- 10 sitesin 7 countries
- Study dates
- Apr 2010to Feb 2012
- 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: Referral Centers
Who may be able to join
- colonic strictures caused by malignant neoplasms, and
- large bowel obstruction due to malignant strictures prior to colectomy.
Who cannot join
- central ischemia,
- any contraindication to GI endoscopy and any procedure to be performed in conjunction with stent placement,
- suspected or impending perforation,
- intra-abdominal abscess/perforation,
- inability to pass wire guide or stent deployment system through the obstructed area,
- patients for whom endoscopic or percutaneous procedures are contraindicated,
- benign disease, and
- coagulopathy.
Trial locations and contacts
10 sites in 7 countries.
10 sites in 7 countries
Spain3 sites
Hospital de Basurto
Bilbao, Bilbao, 48013
Hospital Universitari de Girona
Girona, 17007
Hospital Son Llatzer
Palma de Mallorca, 48013
Canada2 sites
Kingston General Hospital
Kingston, Ontario, K7L5G2
St. Michael's Hospital
Toronto, Ontario, M5B1N8
United Kingdom1 site
University College of London Hospital
London, NW 1 2BU
About this study
The objective of this registry is to compile clinical data on the use of the Evolution® Colonic Stent System for the palliative treatment of colonic obstruction or strictures caused by malignant neoplasms and to relieve acute large bowel obstruction prior to colectomy in patients with malignant strictures.
- Being tested
- Evolution(R) Colonic Stent
- Keywords
- Colonic obstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evolution(R) Colonic StentDevice
Palliative treatment of colonic obstruction or strictures caused by malignant neoplasms and to relieve acute large bowel obstruction prior to colectomy in patients with malignant strictures.
| Study group | Role | What they receive |
|---|---|---|
| Stent Group | Not described Receives: Device: Evolution(R) Colonic Stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relief of obstruction
Measured: At the Conclusion of the Procedure
Secondary outcomes (3)
Implant Duration
Measured: 6 months
Symptoms at Follow-up
Measured: 6 months
Complications
perforation, migration, obstruction, GI bleeding requiring intervention
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2010 (estimated)
- Study startApr 2010
- Primary completionJul 2011
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colonic ObstructionStudies 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cook Group Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01102283
- Sponsor's protocol ID
- 09-022
- Other IDs
- 100041
- Status last verified
- Sep 2013
- First submitted
- 29 Mar 2010
- Last updated
- 18 Sep 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Colonic Obstruction With Cook Evolution® Colonic Stent System
- ClinicalTrials.gov ID
- NCT01102283
- Acronym / sponsor ID
- 09-022
- Keywords
- Colonic obstruction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Cook Group IncorporatedIndustry (pharma, biotech, devices)
- Study start
- Apr 2010
- Primary completion
- Jul 2011 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 13 Apr 2010 (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 objective of this registry is to compile clinical data on the use of the Evolution® Colonic Stent System for the palliative treatment of colonic obstruction or strictures caused by malignant neoplasms and to relieve acute large bowel obstruction prior to colectomy in patients with malignant strictures.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stent Group | – | Device: Evolution(R) Colonic Stent |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Referral Centers
Key inclusion criteria (2 listed)
- colonic strictures caused by malignant neoplasms, and
- large bowel obstruction due to malignant strictures prior to colectomy.
Key exclusion criteria (8 listed)
- central ischemia,
- any contraindication to GI endoscopy and any procedure to be performed in conjunction with stent placement,
- suspected or impending perforation,
- intra-abdominal abscess/perforation,
- inability to pass wire guide or stent deployment system through the obstructed area,
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 |
|---|---|---|
| Evolution(R) Colonic StentPalliative treatment of colonic obstruction or strictures caused by malignant neoplasms and to relieve acute large bowel obstruction prior to colectomy in patients with malignant strictures. | Device | Stent Group |
Primary outcome
Relief of obstruction
Time frame: At the Conclusion of the Procedure
3 secondary outcomes
Implant Duration
Time frame: 6 months
Symptoms at Follow-up
Time frame: 6 months
Complications
Time frame: 6 months
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 18 Sep 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.
The record lists no contact. Use the official record to reach the sponsor.
10 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colonic Obstruction and Colonic Stricture, run by Cook Group Incorporated at 10 sites in 7 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 2 inclusion and 8 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 18 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Spain, Canada, Denmark, France, Italy and 2 more countries. 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?
Relief of obstruction (time frame: At the Conclusion of the Procedure). 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 18 Sep 2013.