Subepithelial Gastrointestinal TumorsNCT07142902
Gastroduodenal Full Thickness Resection Device Registry - gdFTRD® Registry
An observational study of Subepithelial Gastrointestinal Tumors and Adenoma, run by Ovesco Endoscopy AG at 3 sites in Germany.
Trial summary
Endoscopic full-thickness resection (EFTR) is a therapeutic option for the treatment of challenging lesions such as subepithelial tumors (SETs) and epithelial neoplasia extending deeper than the mucosa or associated with significant fibrosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Subepithelial Gastrointestinal Tumors, Adenoma
- What is being tested?
- Data processing only, treatment is not part of the registry
- How many people
- 306 participants
- Where
- 3 sitesGermany
- Study dates
- 21 Aug 2026to Aug 2030
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: All patients of legal age in whom the gdFTRD was used for treatment independently from the registry.
Who may be able to join
- All patients of legal age in whom the gdFTRD was used for treatment in the upper GI tract (stomach and duodenum) independently from the registry and
- who gave informed consent to data processing
Who cannot join
- Patients aged under 18 years
- Patients in whom the colonic FTRD, diagnostic FTRD or non-device assisted EFTR was used for treatment
- Patients who did not give informed consent to data processing
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Germany3 sites, 3 recruiting
- Not yet recruiting
Universitätsklinikum Freiburg - Klinik für Innere Medizin II
Freiburg im Breisgau, Germany, 79106
Armin Küllmer, PD Dr. med., +49 761 27025416, armin.kuellmer@uniklinik-freiburg.de
Armin Küllmer, PD Dr. med.
- Recruiting
RKH Kliniken Ludwigsburg-Bietigheim gGmbH
Ludwigsburg, Germany, 71640
Andreas Wannhoff, PD Dr. med., +49 7141-99-96975, andreas.wannhoff@rkh-gesundheit.de
Andreas Wannhoff, PD Dr. med.
- Recruiting
Robert-Bosch-Krankenhaus
Stuttgart, Germany, 70376
Arthur Schmidt, Prof. Dr., +49 711 8101-2066, arthur.schmidt@rbk.de
Arthur Schmidt, Prof. Dr.
About this study
Endoscopic full-thickness resection (EFTR) is a therapeutic option for the treatment of challenging lesions such as subepithelial tumors (SETs) and epithelial neoplasia extending deeper than the mucosa or associated with significant fibrosis. EFTR may offer a less invasive treatment alternative relative to surgical approaches in selected patients.
The gastroduodenal FTRD System (gdFTRD System) is an instrument for endoscopic full-thickness resection or deep partial wall resection and diagnostic tissue acquisition through removal of suitable lesions in the stomach and duodenum.
The prospectively generated data of the gdFTRD registry shall be used to evaluate the application of the gdFTRD in clinical routine, to verify the acceptability of already known risks and to identify unknown risks and complications.
Read the detailed description
The gdFTRD registry is a registry on cases completed with the gdFTRD System. The gdFTRD System is used for full-thickness resection but the procedure is not part of the study. Only data processing is conducted within the study. For data processing, an EDC system is used.
There are no patient reported outcomes, only physician-entered data on baseline, intervention/procedure, complications/adverse events and follow-up visits.
Automatic plausibility checks have been programmed for quality assurance. Furthermore, warnings and hints will be given on predefined entries not allowed or to double-check values out of normal ranges. No source data verification is planned but data management will check the entries for completeness.
No coding according to MEDRA or similar systems is planned. As the procedure is not part of the study, every participating site must operate according to their own SOPs. The sponsor and CRO have SOPs in place for conducting a study. Furthermore, data protection requirements and all applicable regulations are followed.
The sample size was calculated based results of peer-reviewed publications on the gdFTRD System. As only continuous and categorial variables will be assessed, no separate statistical analysis plan is planned. In case the collected data allows for exploratory post hoc subgroup analysis further tests can be done according to the descriptions in the protocol. Missing data will not be included in the analysis and shall not be imputed.
- Conditions
- Subepithelial Gastrointestinal Tumors, Adenoma
- Being tested
- Data processing only, treatment is not part of the registry
- Keywords
- gdFTRD, gastroduodenal full thickness resection, endoscopic full thickness resection, EFTR
- Medical subject headings
- Adenoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Data processing only, treatment is not part of the registryOther
Treatment with the gdFTRD is part of the clinical routine, the registry only comprises data processing after treatment.
| Study group | Role | What they receive |
|---|---|---|
| All patients of legal age with given informed consent to data processing | All patients of legal age in whom the gdFTRD was used for treatment independently from the registry Receives: Other: Data processing only, treatment is not part of the registry |
What is being measured
The primary outcome is the main question the study is designed to answer.
Technical success
Technical success (i.e. target lesion reached and resected; macroscopically complete)
Measured: Directly post-procedure
Secondary outcomes (3)
Full thickness resection
Full-thickness resection (i.e. histologically confirmed full-thickness resection)
Measured: Up to 14 days post-procedure
R0 resection
R0 resection (i.e. histologically complete lesion resection)
Measured: Up to 14 days post-procedure
Rate of curative resection (in case of malignant tumors)
Rate of curative resection (in case of malignant tumors)
Measured: Up to 14 days post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2025
- Study start21 Aug 2026
- Primary completionAug 2030 (estimated)
- Study completionAug 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Subepithelial Gastrointestinal TumorsStudies 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
- 306 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Ovesco Endoscopy AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- novineon CRO GmbH
- Responsible party
- Sponsor
- Investigators
- Andreas Wannhoff, PD Dr. med., Principal investigator, RKH Kliniken Ludwigsburg-Bietigheim gGmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07142902
- Sponsor's protocol ID
- F-2024-112
- Status last verified
- Oct 2026
- First submitted
- 25 Jul 2025
- Last updated
- 28 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Anonymized data will be used for publication of all participant data.
Publications
Nabi Z, Basha J, Inavolu P, Sayyed M, Ramchandani M, Goud R, Darisetty S, Kotla R, Reddy DN. Exposed versus nonexposed endoscopic full-thickness resection for duodenal subepithelial lesions: a tertiary care center experience (with videos). IGIE. 2023 May 19;2(2):154-160.e2. doi: 10.1016/j.igie.2023.04.004. eCollection 2023 Jun.
PubMed 41647622Hajifathalian K, Ichkhanian Y, Dawod Q, Meining A, Schmidt A, Glaser N, Vosoughi K, Diehl DL, Grimm IS, James T, Templeton AW, Samarasena JB, Chehade NEH, Lee JG, Chang KJ, Mizrahi M, Barawi M, Irani S, Friedland S, Korc P, Aadam AA, Al-Haddad M, Kowalski TE, Smallfield G, Ginsberg GG, Fukami N, Lajin M, Kumta NA, Tang SJ, Naga Y, Amateau SK, Kasmin F, Goetz M, Seewald S, Kumbhari V, Ngamruengphong S, Mahdev S, Mukewar S, Sampath K, Carr-Locke DL, Khashab MA, Sharaiha RZ. Full-thickness resection device (FTRD) for treatment of upper gastrointestinal tract lesions: the first international experience. Endosc Int Open. 2020 Oct;8(10):E1291-E1301. doi: 10.1055/a-1216-1439. Epub 2020 Sep 22.
PubMed 33015330Wannhoff A, Nabi Z, Moons LMG, Haber G, Ge PS, Dertmann T, Deprez PH, Korcz W, Bouvette C, Mueller J, Tribonias G, Grande G, Kim JJ, Weich A, Heinrich H, Mollenkopf M, George J, Pioche M, Azzolini F, Kouladouros K, Boger P, Hayee B, Bilal M, Bastiaansen BAJ, Caca K; Upper GI FTRD Study Group. International, Multicenter Analysis of Endoscopic Full-Thickness Resection of Duodenal Neuroendocrine Tumors. Am J Gastroenterol. 2025 Dec 1;120(12):2800-2809. doi: 10.14309/ajg.0000000000003409. Epub 2025 Mar 13.
PubMed 40079474Meier 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 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gastroduodenal Full Thickness Resection Device Registry - gdFTRD® Registry
- ClinicalTrials.gov ID
- NCT07142902
- Acronym / sponsor ID
- F-2024-112
- Conditions
- Subepithelial Gastrointestinal Tumors, Adenoma
- Keywords
- gdFTRD, gastroduodenal full thickness resection, endoscopic full thickness resection, EFTR
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 306 participants (estimated)
- Lead sponsor
- Ovesco Endoscopy AGIndustry (pharma, biotech, devices)
- Collaborators
- novineon CRO GmbH
- Study start
- 21 Aug 2026 (actual)
- Primary completion
- Aug 2030 (estimated)
- Study completion
- Aug 2030 (estimated)
- First posted
- 27 Aug 2025 (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.
Endoscopic full-thickness resection (EFTR) is a therapeutic option for the treatment of challenging lesions such as subepithelial tumors (SETs) and epithelial neoplasia extending deeper than the mucosa or associated with significant fibrosis. EFTR may offer a less invasive treatment alternative relative to surgical approaches in selected patients.
The gastroduodenal FTRD System (gdFTRD System) is an instrument for endoscopic full-thickness resection or deep partial wall resection and diagnostic tissue acquisition through removal of suitable lesions in the stomach and duodenum.
The prospectively generated data of the gdFTRD registry shall be used to evaluate the application of the gdFTRD in clinical routine, to verify the acceptability of already known risks and to identify unknown risks and complications.
Detailed description
The gdFTRD registry is a registry on cases completed with the gdFTRD System. The gdFTRD System is used for full-thickness resection but the procedure is not part of the study. Only data processing is conducted within the study. For data processing, an EDC system is used.
There are no patient reported outcomes, only physician-entered data on baseline, intervention/procedure, complications/adverse events and follow-up visits.
Automatic plausibility checks have been programmed for quality assurance. Furthermore, warnings and hints will be given on predefined entries not allowed or to double-check values out of normal ranges. No source data verification is planned but data management will check the entries for completeness.
No coding according to MEDRA or similar systems is planned. As the procedure is not part of the study, every participating site must operate according to their own SOPs. The sponsor and CRO have SOPs in place for conducting a study. Furthermore, data protection requirements and all applicable regulations are followed.
The sample size was calculated based results of peer-reviewed publications on the gdFTRD System. As only continuous and categorial variables will be assessed, no separate statistical analysis plan is planned. In case the collected data allows for exploratory post hoc subgroup analysis further tests can be done according to the descriptions in the protocol. Missing data will not be included in the analysis and shall not be imputed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All patients of legal age with given informed consent to data processing | – | Other: Data processing only, treatment is not part of the registryAll patients of legal age in whom the gdFTRD was used for treatment independently from the registry |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients of legal age in whom the gdFTRD was used for treatment independently from the registry.
Key inclusion criteria (2 listed)
- All patients of legal age in whom the gdFTRD was used for treatment in the upper GI tract (stomach and duodenum) independently from the registry and
- who gave informed consent to data processing
Key exclusion criteria (3 listed)
- Patients aged under 18 years
- Patients in whom the colonic FTRD, diagnostic FTRD or non-device assisted EFTR was used for treatment
- Patients who did not give informed consent to data processing
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 |
|---|---|---|
| Data processing only, treatment is not part of the registryTreatment with the gdFTRD is part of the clinical routine, the registry only comprises data processing after treatment. | Other | All patients of legal age with given informed consent to data processing |
Primary outcome
Technical success
Time frame: Directly post-procedure
Technical success (i.e. target lesion reached and resected; macroscopically complete)
3 secondary outcomes
Full thickness resection
Time frame: Up to 14 days post-procedure
R0 resection
Time frame: Up to 14 days post-procedure
Rate of curative resection (in case of malignant tumors)
Time frame: Up to 14 days post-procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
- Background: PubMed 41647622Nabi Z, Basha J, Inavolu P, Sayyed M, Ramchandani M, Goud R, Darisetty S, Kotla R, Reddy DN. Exposed versus nonexposed endoscopic full-thickness resection for duodenal subepithelial lesions: a tertiary care center experience (with videos). IGIE. 2023 May 19;2(2):154-160.e2. doi: 10.1016/j.igie.2023.04.004. eCollection 2023 Jun.
- Background: PubMed 33015330Hajifathalian K, Ichkhanian Y, Dawod Q, Meining A, Schmidt A, Glaser N, Vosoughi K, Diehl DL, Grimm IS, James T, Templeton AW, Samarasena JB, Chehade NEH, Lee JG, Chang KJ, Mizrahi M, Barawi M, Irani S, Friedland S, Korc P, Aadam AA, Al-Haddad M, Kowalski TE, Smallfield G, Ginsberg GG, Fukami N, Lajin M, Kumta NA, Tang SJ, Naga Y, Amateau SK, Kasmin F, Goetz M, Seewald S, Kumbhari V, Ngamruengphong S, Mahdev S, Mukewar S, Sampath K, Carr-Locke DL, Khashab MA, Sharaiha RZ. Full-thickness resection device (FTRD) for treatment of upper gastrointestinal tract lesions: the first international experience. Endosc Int Open. 2020 Oct;8(10):E1291-E1301. doi: 10.1055/a-1216-1439. Epub 2020 Sep 22.
- Background: PubMed 40079474Wannhoff A, Nabi Z, Moons LMG, Haber G, Ge PS, Dertmann T, Deprez PH, Korcz W, Bouvette C, Mueller J, Tribonias G, Grande G, Kim JJ, Weich A, Heinrich H, Mollenkopf M, George J, Pioche M, Azzolini F, Kouladouros K, Boger P, Hayee B, Bilal M, Bastiaansen BAJ, Caca K; Upper GI FTRD Study Group. International, Multicenter Analysis of Endoscopic Full-Thickness Resection of Duodenal Neuroendocrine Tumors. Am J Gastroenterol. 2025 Dec 1;120(12):2800-2809. doi: 10.14309/ajg.0000000000003409. Epub 2025 Mar 13.
- Background: 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. Anonymized data will be used for publication of all participant data.
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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.
Andreas Wannhoff, PD Dr. med. principal investigator
RKH Kliniken Ludwigsburg-Bietigheim gGmbH
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Subepithelial Gastrointestinal Tumors and Adenoma, run by Ovesco Endoscopy AG at 3 sites 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 3 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: looking for participants now, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bettina Stritzke (+49 707196528-174, bettina.stritzke@ovesco.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Technical success (time frame: Directly post-procedure). 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 NCT07142902, which also lists 4 linked publications.
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 28 Oct 2026.