Colorectal CancerPhase 2NCT01056796
Compression Anastomosis For Low Anterior Resection in Previously Radiated Patients Using the CAR™ 27
A Phase 2 study testing CAR™ 27 in people with Colorectal Cancer, run by Niti Medical Technologies Ltd. at 1 site in Belgium.
Trial summary
The purpose of this study is: Evaluation of the safety and effectiveness of the Compression Anastomosis Ring (CAR™ 27) device for creation of circular, colorectal anastomoses in previously radiated patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- CAR™ 27
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteBelgium
- Study dates
- Jan 2010to May 2012
- Phase
- Phase 2
- 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
Who may be able to join
- Patient is ≥ 18 years old.
- Patient is scheduled for a non-emergency TME and low anterior resection (< 10cm from the anal verge).
- Patient has been radiated to the pelvic area 6-8 weeks prior to the study.
- Subject signs and dates a written informed consent form (ICF) and indicates an understanding of the study procedures.
Who cannot join
- Patient has known allergy to nickel.
- Patient undergoing an emergency procedure or has a diagnosis of bowel obstruction, bowel strangulation, peritonitis, bowel perforation, local or systemic infection, ischemic bowel, carcinomatosis or inflammatory bowel disease.
- Patients are participating in another clinical trial which may affect this study's outcomes.
- Patient has been taking regular steroid medication.
- Patient has contraindications to general anesthesia.
- Patient has preexisting sphincter problems or evidence of extensive local disease in the pelvis.
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
University Hospital, Gasthuisberg
Leuven
Andre D'Hoore, Professor, +32 (16) 344265, andre.dhoore@uz.kuleuven.ac.be
Guido Van Ermen, Mr., +32 (16) 344265, guido.vanermen@uz.kuleuven.ac.be
About this study
The purpose of this study is:
Evaluation of the safety and effectiveness of the Compression Anastomosis Ring (CAR™ 27) device for creation of circular, colorectal anastomoses in previously radiated patients.
- Conditions
- Colorectal Cancer
- Being tested
- CAR™ 27
- Keywords
- compression anastomosis, Colorectal cancer, Low anterior resection, Radiated to the pelvic area, Radiotherapy
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAR™ 27Device
Also called Compression Anastomosis Ring
Creation of a low colorectal (side or pouch low rectal) compression anastomosis in previously radiated patients
| Study group | Role | What they receive |
|---|---|---|
| CAR™ 27 | Experimental | Any patient with a diagnosis of colorectal cancer that has been previously radiated to the pelvic area (6-8 weeks prior to surgery) and that is electively scheduled for an open or laparoscopic total mesorectal excision (TME) and low anterior resection surgery (< 10cm from the anal verge) which requires the creation of an anastomosis, will be offered participation in this study. Receives: Device: CAR™ 27 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate for the occurrence of adverse events related to the use of the CAR™ 27 device, include anastomotic leak, bleeding, ring evacuation and strictures at 6 months.
Measured: Approx. 1 year
Secondary outcomes (1)
Evaluation of the creation of a functioning CAR™ 27 anastomosis in radiated patients
Measured: Approx. 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2010 (estimated)
- Study startJan 2010
- Primary completionMay 2012 (estimated)
- Study completionMay 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Niti Medical Technologies Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University Hospital, Gasthuisberg
- Investigators
- Andre D'Hoore, Professor, Principal investigator, Gasthuisberg University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01056796
- Sponsor's protocol ID
- Version: January 6, 2010
- Status last verified
- Jan 2010
- First submitted
- 25 Jan 2010
- Last updated
- 30 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Compression Anastomosis For Low Anterior Resection in Previously Radiated Patients Using the CAR™ 27
- ClinicalTrials.gov ID
- NCT01056796
- Acronym / sponsor ID
- Version: January 6, 2010
- Conditions
- Colorectal Cancer
- Keywords
- compression anastomosis, Colorectal cancer, Low anterior resection, Radiated to the pelvic area, Radiotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Niti Medical Technologies Ltd.Industry (pharma, biotech, devices)
- Collaborators
- University Hospital, Gasthuisberg
- Study start
- Jan 2010
- Primary completion
- May 2012 (estimated)
- Study completion
- May 2012 (estimated)
- First posted
- 26 Jan 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 purpose of this study is:
Evaluation of the safety and effectiveness of the Compression Anastomosis Ring (CAR™ 27) device for creation of circular, colorectal anastomoses in previously radiated patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CAR™ 27 | Experimental | Device: CAR™ 27Any patient with a diagnosis of colorectal cancer that has been previously radiated to the pelvic area (6-8 weeks prior to surgery) and that is electively scheduled for an open or laparoscopic total mesorectal excision (TME) and low anterior resection surgery (< 10cm from the anal verge) which requires the creation of an anastomosis, will be offered participation in this study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient is ≥ 18 years old.
- Patient is scheduled for a non-emergency TME and low anterior resection (< 10cm from the anal verge).
- Patient has been radiated to the pelvic area 6-8 weeks prior to the study.
- Subject signs and dates a written informed consent form (ICF) and indicates an understanding of the study procedures.
Key exclusion criteria (6 listed)
- Patient has known allergy to nickel.
- Patient undergoing an emergency procedure or has a diagnosis of bowel obstruction, bowel strangulation, peritonitis, bowel perforation, local or systemic infection, ischemic bowel, carcinomatosis or inflammatory bowel disease.
- Patients are participating in another clinical trial which may affect this study's outcomes.
- Patient has been taking regular steroid medication.
- Patient has contraindications to general anesthesia.
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 |
|---|---|---|
| CAR™ 27Also: Compression Anastomosis RingCreation of a low colorectal (side or pouch low rectal) compression anastomosis in previously radiated patients | Device | CAR™ 27 |
Primary outcome
To evaluate for the occurrence of adverse events related to the use of the CAR™ 27 device, include anastomotic leak, bleeding, ring evacuation and strictures at 6 months.
Time frame: Approx. 1 year
1 secondary outcome
Evaluation of the creation of a functioning CAR™ 27 anastomosis in radiated patients
Time frame: Approx. 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2011.
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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.
Andre D'Hoore, Professor principal investigator
Gasthuisberg University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CAR™ 27 in people with Colorectal Cancer, run by Niti Medical Technologies Ltd. at 1 site in Belgium.
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 6 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: status not confirmed, as of the sponsor's last update on 30 Jun 2011. 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 Belgium. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Andre D'Hoore, Professor (+32 (16) 344265, andre.dhoore@uz.kuleuven.ac.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate for the occurrence of adverse events related to the use of the CAR™ 27 device, include anastomotic leak, bleeding, ring evacuation and strictures at 6 months. (time frame: Approx. 1 year). 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 30 Jun 2011.