Colonic NeoplasmsPhase 4NCT01056913
NITI CAR27 (ColonRing) Compression Anastomosis in Colorectal Surgery
A Phase 4 study testing Compression Anastomosis Device and follow-up colonoscopy in people with Colonic Neoplasms and Rectal Neoplasms, run by St John of God Hospital, Vienna.
Trial summary
After resection of diseased segments of the large intestine, the continuity of the intestine has to be restored. This can be done by suturing or with so called stapling devices. In addition since 2 centuries compression rings are used to connect the intestine after resection. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Colonic Neoplasms, Rectal Neoplasms, Diverticulitis
- What is being tested?
- Compression Anastomosis Device and follow-up colonoscopy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- No sites listed yet
- Study dates
- Oct 2008to Sep 2010
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- benign and malign lesions of the colon and rectum
Who cannot join
- advanced peritonitis (putrid, feculent)
About this study
Official title: Compression Anastomosis: Initial Clinical Experience With the ColonRingTM
After resection of diseased segments of the large intestine, the continuity of the intestine has to be restored. This can be done by suturing or with so called stapling devices. In addition since 2 centuries compression rings are used to connect the intestine after resection. The NITICAR27 device is a novel compression anastomosis device. The investigators want to prove if this novel device can be compared to commonly used stapling devices concerning anastomotic leakage, bleeding and stenosis.
- Conditions
- Colonic Neoplasms, Rectal Neoplasms, Diverticulitis, Inflammatory Bowel Diseases, Rectal Prolapse
- Being tested
- Compression Anastomosis Device, follow-up colonoscopy
- Keywords
- anastomotic leakage, bleeding from the anastomotic region, anastomotic stenosis
- Medical subject headings
- Colonic Neoplasms, Rectal Neoplasms, Diverticulitis, Inflammatory Bowel Diseases, Rectal Prolapse, Anastomotic Leak
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Compression Anastomosis DeviceDevice
Also called ColonRing, BioDynamix Anastomosis
Restoring intestinal continuity using the NITI CAR27 device
follow-up colonoscopyOther
endoscopic exploration of anastomosis after complete healing
| Study group | Role | What they receive |
|---|---|---|
| NITI CAR27 (ColonRing) | Other | Not described Receives: Device: Compression Anastomosis Device; Other: follow-up colonoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anastomotic Leakage
Measured: 4-8 weeks
Secondary outcomes (1)
Clinical Relevant Stenosis
Measured: six months
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 startOct 2008
- Primary completionSep 2010
- Study completionSep 2010
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colonic NeoplasmsStudies 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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- St John of God Hospital, Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bernhard Dauser, MD, St John of God Hospital, Vienna
- Investigators
- Friedrich Herbst, MD, FRCS, Principal investigator, St John of God Hospital, Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01056913
- Sponsor's protocol ID
- CT2
- Status last verified
- Dec 2013
- First submitted
- 24 Jan 2010
- Last updated
- 29 Jan 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Dauser B, Winkler T, Loncsar G, Herbst F. Compression anastomosis revisited: prospective audit of short- and medium-term outcomes in 62 rectal anastomoses. World J Surg. 2011 Aug;35(8):1925-32. doi: 10.1007/s00268-011-1135-2.
PubMed 21541799
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Compression Anastomosis: Initial Clinical Experience With the ColonRingTM
- ClinicalTrials.gov ID
- NCT01056913
- Acronym / sponsor ID
- CT2
- Conditions
- Colonic Neoplasms, Rectal Neoplasms, Diverticulitis, Inflammatory Bowel Diseases, Rectal Prolapse
- Keywords
- anastomotic leakage, bleeding from the anastomotic region, anastomotic stenosis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- St John of God Hospital, ViennaUniversity, hospital or other
- Study start
- Oct 2008
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 26 Jan 2010 (estimated)
- Results
- Posted 29 Jan 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
After resection of diseased segments of the large intestine, the continuity of the intestine has to be restored. This can be done by suturing or with so called stapling devices. In addition since 2 centuries compression rings are used to connect the intestine after resection. The NITICAR27 device is a novel compression anastomosis device. The investigators want to prove if this novel device can be compared to commonly used stapling devices concerning anastomotic leakage, bleeding and stenosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NITI CAR27 (ColonRing) | Other | Device: Compression Anastomosis Device, Other: follow-up colonoscopy |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- benign and malign lesions of the colon and rectum
Key exclusion criteria (1 listed)
- advanced peritonitis (putrid, feculent)
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 |
|---|---|---|
| Compression Anastomosis DeviceAlso: ColonRing, BioDynamix AnastomosisRestoring intestinal continuity using the NITI CAR27 device | Device | NITI CAR27 (ColonRing) |
| follow-up colonoscopyendoscopic exploration of anastomosis after complete healing | Other | NITI CAR27 (ColonRing) |
Primary outcome
Anastomotic Leakage
Time frame: 4-8 weeks
1 secondary outcome
Clinical Relevant Stenosis
Time frame: six months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 21541799Dauser B, Winkler T, Loncsar G, Herbst F. Compression anastomosis revisited: prospective audit of short- and medium-term outcomes in 62 rectal anastomoses. World J Surg. 2011 Aug;35(8):1925-32. doi: 10.1007/s00268-011-1135-2.
- About BioDynamix AnastomosisLink 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.
Friedrich Herbst, MD, FRCS principal investigator
St John of God Hospital, Vienna
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Compression Anastomosis Device and follow-up colonoscopy in people with Colonic Neoplasms and Rectal Neoplasms, run by St John of God Hospital, Vienna.
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 1 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 29 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
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 29 Jan 2014). 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?
Anastomotic Leakage (time frame: 4-8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01056913, which also lists 1 linked publication.
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 29 Jan 2014.