Feasibility, ComplicationsRESETNCT03096236
Endoscopic Full-thickness Resection of Gastric Subepithelial Tumors With the gFTRD
An observational study of Feasibility, Complications, run by Kliniken Ludwigsburg-Bietigheim gGmbH at 1 site in Germany.
Trial summary
Subepithelial gastric tumors are rare and usually detected incidentally. Most subepithelial tumors (SET) are benign but up to 13% of all lesions can be malignant. Histology after needle biopsy often brings no clear diagnosis in SET, so further strategy often remains unclear. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Feasibility, Complications
- What is being tested?
- EFTR
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- 1 siteGermany
- Study dates
- 1 Mar 2017to 1 Sep 2019
- 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with gastric SET
Who may be able to join
- Age > 18 years
- Gastric SET up to 15 mm (measurement: endoscopic ultrasound)
Who cannot join
- Age < 18 years
- Gastric SET > 15 mm and/or large extramural part
- Criteria of Lipoma (endoscopic ultrasound)
- Positive lymph nodes (endoscopic ultrasound)
- Stenosis (Esophagus)
- Diverticulum (Esophagus)
- Pregnancy or Nursing period
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Klinikum Ludwigsburg
Ludwigsburg
Benjamin Meier, benjamin.meier@kliniken-lb.de
Karel Caca, 004971419967201, karel.caca@kliniken-lb.de
About this study
Subepithelial gastric tumors are rare and usually detected incidentally. Most subepithelial tumors (SET) are benign but up to 13% of all lesions can be malignant. Histology after needle biopsy often brings no clear diagnosis in SET, so further strategy often remains unclear. Surveillance endoscopy can be associated with the risk of progression. Endoscopic resection usually is difficult, associated with high risk of complications and sometimes is not feasible. Surgical resection is also associated with a risk of complications and often refused by the patients. With the developement of the gFTRD-System gastric SET can now be resected endoscopically. The advantage of this technique is the complete resection and a full-thickness resections specimen for are definite histology.
- Conditions
- Feasibility, Complications
- Being tested
- EFTR
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EFTRDevice
EFTR with the FTRD developed for gastric resection (gFTRD).
What is being measured
The primary outcome is the main question the study is designed to answer.
Technical success
Successful enbloc- and macroscopically complete resection
Measured: 1 minute (immediate)
Secondary outcomes (5)
R0-Resection
Histologically confirmed complete resection
Measured: three days
Histologically confirmed full thickness resection
Histologically confirmed full thickness resection
Measured: three days
Procedure-associated complications
Procedure-associated complications such as bleeding or perforation
Measured: three months
Necessity of surgical treatment
Necessity of surgical treatment
Measured: three months
Residual or recurrent adenoma/carcinoma at endoscopic follow up
Residual or recurrent adenoma/carcinoma at endoscopic follow up
Measured: three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2017
- Study start1 Mar 2017
- Primary completion1 Mar 2019 (estimated)
- Study completion1 Sep 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Feasibility, ComplicationsStudies 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
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kliniken Ludwigsburg-Bietigheim gGmbH
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03096236
- Sponsor's protocol ID
- RESET
- Acronym
- RESET
- Status last verified
- Sep 2017
- First submitted
- 23 Mar 2017
- Last updated
- 18 Sep 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Meier B, Schmidt A, Glaser N, Meining A, Walter B, Wannhoff A, Riecken B, Caca K. Endoscopic full-thickness resection of gastric subepithelial tumors with the gFTRD-system: a prospective pilot study (RESET trial). Surg Endosc. 2020 Feb;34(2):853-860. doi: 10.1007/s00464-019-06839-2. Epub 2019 Jun 11.
PubMed 31187233
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endoscopic Full-thickness Resection of Gastric Subepithelial Tumors With the gFTRD
- ClinicalTrials.gov ID
- NCT03096236
- Acronym / sponsor ID
- RESET / RESET
- Conditions
- Feasibility, Complications
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Kliniken Ludwigsburg-Bietigheim gGmbHUniversity, hospital or other
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 1 Mar 2019 (estimated)
- Study completion
- 1 Sep 2019 (estimated)
- First posted
- 30 Mar 2017 (actual)
- 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.
Subepithelial gastric tumors are rare and usually detected incidentally. Most subepithelial tumors (SET) are benign but up to 13% of all lesions can be malignant. Histology after needle biopsy often brings no clear diagnosis in SET, so further strategy often remains unclear. Surveillance endoscopy can be associated with the risk of progression. Endoscopic resection usually is difficult, associated with high risk of complications and sometimes is not feasible. Surgical resection is also associated with a risk of complications and often refused by the patients. With the developement of the gFTRD-System gastric SET can now be resected endoscopically. The advantage of this technique is the complete resection and a full-thickness resections specimen for are definite histology.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with gastric SET
Key inclusion criteria (2 listed)
- Age > 18 years
- Gastric SET up to 15 mm (measurement: endoscopic ultrasound)
Key exclusion criteria (7 listed)
- Age < 18 years
- Gastric SET > 15 mm and/or large extramural part
- Criteria of Lipoma (endoscopic ultrasound)
- Positive lymph nodes (endoscopic ultrasound)
- Stenosis (Esophagus)
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 |
|---|---|---|
| EFTREFTR with the FTRD developed for gastric resection (gFTRD). | Device | – |
Primary outcome
Technical success
Time frame: 1 minute (immediate)
Successful enbloc- and macroscopically complete resection
5 secondary outcomes
R0-Resection
Time frame: three days
Histologically confirmed full thickness resection
Time frame: three days
Procedure-associated complications
Time frame: three months
Necessity of surgical treatment
Time frame: three months
Residual or recurrent adenoma/carcinoma at endoscopic follow up
Time frame: three months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2017.
- Derived from this study: PubMed 31187233Meier B, Schmidt A, Glaser N, Meining A, Walter B, Wannhoff A, Riecken B, Caca K. Endoscopic full-thickness resection of gastric subepithelial tumors with the gFTRD-system: a prospective pilot study (RESET trial). Surg Endosc. 2020 Feb;34(2):853-860. doi: 10.1007/s00464-019-06839-2. Epub 2019 Jun 11.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Feasibility, Complications, run by Kliniken Ludwigsburg-Bietigheim gGmbH 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 2 inclusion and 7 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 18 Sep 2017. 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.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Technical success (time frame: 1 minute (immediate)). 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 NCT03096236, 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 18 Sep 2017.