Gastric Subepitelial MassPhase 1EndoResectNCT01105728
Endoscopic Resection of Gastric Subepithelial Masses, EndoResect Study
A Phase 1 study testing Endoscopic resection in people with Gastric Subepitelial Mass, run by Technical University of Munich at 1 site in Germany.
Trial summary
Gastric subepithelial masses might harbour gastrointestinal stromal tumors, which should get resected because of their malignant potential. To minimize the associated surgical trauma endoscopic endoluminal resection is favorable. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastric Subepitelial Mass
- What is being tested?
- Endoscopic resection
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2010to Jan 2012
- Phase
- Phase 1
- 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
- Endosonographically suspicous gastric subepithelial mass <=3 cm.
Who cannot join
- American Society of Anesthesiologists (ASA) classes IV or V
- Pregnancy
- Bleeding disorders
- Contraindications for endoscopy
- Endosonographically shown large vessels in the area for resection
Trial locations and contacts
1 site in 1 country.
About this study
Gastric subepithelial masses might harbour gastrointestinal stromal tumors, which should get resected because of their malignant potential. To minimize the associated surgical trauma endoscopic endoluminal resection is favorable. Therefore in the current study endoscopic resection of gastric subepithelial masses is investigated. Since there is a certain risk of perforation due to the procedure, perforations get closed by placement of endoscopic clips (over-the-scope-clip [OTSC] clips).
Read the detailed description
During an initial pilot phase 8 patients receive endoscopic resection under laparoscopic control. Thereafter and after positive initial results sole endoluminal endoscopy is done for a total of 38 patients.
- Conditions
- Gastric Subepitelial Mass
- Being tested
- Endoscopic resection
- Keywords
- Gastric subepitelial mass, Endoscopic full thickness resection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic resectionProcedure or surgery
Endoscopic resection of the gastric subepithelial mass
| Study group | Role | What they receive |
|---|---|---|
| Study arm | Experimental | Endoscopic resection Receives: Procedure: Endoscopic resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
R0 Resection
Rate of R0 resections by an endoscopic approach for resection.
Measured: 30 minutes
Secondary outcomes (1)
Safety
Rate of complications
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2010 (estimated)
- Study startApr 2010
- Primary completionJan 2012
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric Subepitelial MassStudies of the same condition, open and under way.
- More trials run by Technical University of MunichThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 38 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Technical University of Munich
- Sponsor type
- University, hospital or other
- Investigators
- Alexander Meining, MD, Principal investigator, Klinikum rechts der IsarStefan von Delius, MD, Principal investigator, Klinikum rechts der IsarHubertus Feußner, MD, Principal investigator, Klinikum rechts der IsarDirk Wilhelm, MD, Principal investigator, Klinikum rechts der Isar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01105728
- Sponsor's protocol ID
- 2632/09
- Acronym
- EndoResect
- Status last verified
- Apr 2012
- First submitted
- 15 Apr 2010
- Last updated
- 24 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endoscopic Resection of Gastric Subepithelial Masses, EndoResect Study
- ClinicalTrials.gov ID
- NCT01105728
- Acronym / sponsor ID
- EndoResect / 2632/09
- Conditions
- Gastric Subepitelial Mass
- Keywords
- Gastric subepitelial mass, Endoscopic full thickness resection
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- Technical University of MunichUniversity, hospital or other
- Study start
- Apr 2010
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 16 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.
Gastric subepithelial masses might harbour gastrointestinal stromal tumors, which should get resected because of their malignant potential. To minimize the associated surgical trauma endoscopic endoluminal resection is favorable. Therefore in the current study endoscopic resection of gastric subepithelial masses is investigated. Since there is a certain risk of perforation due to the procedure, perforations get closed by placement of endoscopic clips (over-the-scope-clip [OTSC] clips).
Detailed description
During an initial pilot phase 8 patients receive endoscopic resection under laparoscopic control. Thereafter and after positive initial results sole endoluminal endoscopy is done for a total of 38 patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study arm | Experimental | Procedure: Endoscopic resectionEndoscopic resection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Endosonographically suspicous gastric subepithelial mass <=3 cm.
Key exclusion criteria (5 listed)
- American Society of Anesthesiologists (ASA) classes IV or V
- Pregnancy
- Bleeding disorders
- Contraindications for endoscopy
- Endosonographically shown large vessels in the area for resection
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 |
|---|---|---|
| Endoscopic resectionEndoscopic resection of the gastric subepithelial mass | Procedure or surgery | Study arm |
Primary outcome
R0 Resection
Time frame: 30 minutes
Rate of R0 resections by an endoscopic approach for resection.
1 secondary outcome
Safety
Time frame: 30 minutes
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 24 Apr 2012.
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.
Alexander Meining, MD principal investigator
Klinikum rechts der Isar
Stefan von Delius, MD principal investigator
Klinikum rechts der Isar
Hubertus Feußner, MD principal investigator
Klinikum rechts der Isar
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Endoscopic resection in people with Gastric Subepitelial Mass, run by Technical University of Munich at 1 site in Germany.
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 5 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 24 Apr 2012. 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 Germany. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
R0 Resection (time frame: 30 minutes). 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 24 Apr 2012.