Colonic PolypsTAEMRNCT00966420
Traction Assisted Polypectomy of the Intestine
A study testing traction assisted endoscopic mucosa resection in people with Colonic Polyps and Adenomatous Polyps, run by St John of God Hospital, Vienna at 1 site in Austria.
Trial summary
The purpose of the study is to verify if the ablation of lesions (polyps, adenomas) in the large (and small) intestine can be facilitated by using a traction on the lesions. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Colonic Polyps, Adenomatous Polyps
- What is being tested?
- traction assisted endoscopic mucosa resection
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteAustria
- Study dates
- Jul 2009to Mar 2010
- Phase
- Interventional
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- benign lesions in the large and small intestine
- diameter of lesion smaller than 3cm
Who cannot join
- malign lesions of the large and small intestine
- diameter of lesions larger than 3cm
Trial locations and contacts
1 site in 1 country.
Austria1 site
Departement of Surgery, St John of God Hospital
Vienna, State of Vienna, 1020
About this study
Official title: Traction Assisted Endoscopic Mucosa Resection (TAEMR)
The purpose of the study is to verify if the ablation of lesions (polyps, adenomas) in the large (and small) intestine can be facilitated by using a traction on the lesions.
Read the detailed description
We want to facilitate the ablation of lesions (polyps, adenomas) in the large (and small) intestine by using a traction assisted technique.
The traction will be performed by using a haemoclip connected to surgical suture materials. The haemoclip will be fixed to the intestinal mucosa next to the lesion and a loop will be mounted to perform an endoscopic mucosal resection.
The aim of the study is to show the feasibility of this technique.
- Conditions
- Colonic Polyps, Adenomatous Polyps
- Being tested
- traction assisted endoscopic mucosa resection
- Medical subject headings
- Colonic Polyps, Adenomatous Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
traction assisted endoscopic mucosa resectionDevice
Also called endoscopic polypectomy
A haemoclip is connected to suture material and will be fixed (next) to a polyp to allow traction and lifting the lesion in order to facilitate its resection with a loop.
| Study group | Role | What they receive |
|---|---|---|
| mucosa resection | Experimental | Not described Receives: Device: traction assisted endoscopic mucosa resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
ablation of lesion in toto
Measured: 1 week after intervention
Secondary outcomes (1)
complications after resection
Measured: within one week after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2009 (estimated)
- Study startJul 2009
- Primary completionMar 2010
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colonic PolypsStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- St John of God Hospital, Vienna
- Sponsor type
- University, hospital or other
- Investigators
- Bernhard Dauser, MD, Principal investigator, St John of God Hospital, Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00966420
- Sponsor's protocol ID
- SJOG-01
- Acronym
- TAEMR
- Status last verified
- Mar 2010
- First submitted
- 25 Aug 2009
- Last updated
- 30 Mar 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Traction Assisted Endoscopic Mucosa Resection (TAEMR)
- ClinicalTrials.gov ID
- NCT00966420
- Acronym / sponsor ID
- TAEMR / SJOG-01
- Conditions
- Colonic Polyps, Adenomatous Polyps
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- St John of God Hospital, ViennaUniversity, hospital or other
- Study start
- Jul 2009
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 27 Aug 2009 (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 the study is to verify if the ablation of lesions (polyps, adenomas) in the large (and small) intestine can be facilitated by using a traction on the lesions.
Detailed description
We want to facilitate the ablation of lesions (polyps, adenomas) in the large (and small) intestine by using a traction assisted technique.
The traction will be performed by using a haemoclip connected to surgical suture materials. The haemoclip will be fixed to the intestinal mucosa next to the lesion and a loop will be mounted to perform an endoscopic mucosal resection.
The aim of the study is to show the feasibility of this technique.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| mucosa resection | Experimental | Device: traction assisted endoscopic mucosa resection |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- benign lesions in the large and small intestine
- diameter of lesion smaller than 3cm
Key exclusion criteria (2 listed)
- malign lesions of the large and small intestine
- diameter of lesions larger than 3cm
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 |
|---|---|---|
| traction assisted endoscopic mucosa resectionAlso: endoscopic polypectomyA haemoclip is connected to suture material and will be fixed (next) to a polyp to allow traction and lifting the lesion in order to facilitate its resection with a loop. | Device | mucosa resection |
Primary outcome
ablation of lesion in toto
Time frame: 1 week after intervention
1 secondary outcome
complications after resection
Time frame: within one week after intervention
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 30 Mar 2010.
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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.
Bernhard Dauser, MD principal investigator
St John of God Hospital, Vienna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing traction assisted endoscopic mucosa resection in people with Colonic Polyps and Adenomatous Polyps, run by St John of God Hospital, Vienna at 1 site in Austria.
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 2 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 30 Mar 2010. 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 Austria. 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?
ablation of lesion in toto (time frame: 1 week after intervention). 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 Mar 2010.