Colorectal AdenomasWALL-RESECTNCT02362126
Endoscopic Full Thickness Resection in the Lower GI Tract With the "Full Thickness Resection Device"
An observational study of Colorectal Adenomas and Submucosal Tumors, run by Kliniken Ludwigsburg-Bietigheim gGmbH at 1 site in Germany.
Trial summary
Observational prospective multicenter study to investigate efficacy and safety of endoscopic full thickness resection in the lower GI tract using a novel over-the-scope full thickness resection device. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Adenomas, Submucosal Tumors
- What is being tested?
- Endoscopic full thickness resection (EFTR)
- Type of treatment
- Medical device
- How many people
- 80 participants
- Where
- 1 siteGermany
- Study dates
- Feb 2015to Feb 2017
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with colorectal lesions which are difficult or impossible to resect with conventional endoscopic methods
Who may be able to join
- Age > 18 y
- Adenoma with negtive lifting sign
- Adenoma involving or next to a diverticulum
- Adenoma involving or next to the appendical orifice
- T1 carcinoma with indication for endoscopic (re-)resection
- Subepithelial colorectal tumor with indication for resection
Who cannot join
- Lesions >3 cm
- T1 carcinomas with known high-risk features (submucosal infiltration>1000 um, invasion of lymphatic vessels, poor differentiation (G3))
- Lesions in the upper GI tract
- Patients with colorectal stenosis
- Patinets not able to undergo informed consent
- Pregnancy
- Patients with urgent indication for dual thrombocyte aggregation inhibition
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Klinikum Ludwigsburg
Ludwigsburg, Baden-Wurttemberg, 71640
Arthur Schmidt, MD, +49-7141-9967201, arthur.schmidt@kliniken-lb.de
Karel Caca, MD, PhD, +49-7141-9967201, karel.caca@kliniken-lb.de
About this study
Official title: Endoscopic Full Thickness Resection in the Lower GI Tract With the "Full Thickness Resection Device"- A Prospective Multicenter Trial
Observational prospective multicenter study to investigate efficacy and safety of endoscopic full thickness resection in the lower GI tract using a novel over-the-scope full thickness resection device.
Read the detailed description
The FTRD ("Full Thickness Resection Device", Ovesco Endoscopy, Tübingen, Germany) is an over the scope device consisting of a transparent cap with a preloaded monofilament snare and and a 14 mm modified Over-the-scope Clip. The device is CE marked for full thickness resection in the lower GI tract.
The study was designed to investigate efficacy and safety of this device for full thickness resection of colorectal lesions.
- Conditions
- Colorectal Adenomas, Submucosal Tumors
- Being tested
- Endoscopic full thickness resection (EFTR)
- Keywords
- Endoscopic full thickness resection, EFTR, FTRD, OTSC
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic full thickness resection (EFTR)Device
Patients undergo EFTR using the FTRD
| Study group | Role | What they receive |
|---|---|---|
| Patients undergoing EFTR | Patients with non-lifting adenomas, adnomas at difficult anaotomic locations , T1-carcinomas or submucosal colorectal tumors Receives: Device: Endoscopic full thickness resection (EFTR) |
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: Immediate
R0-Resection
Histologically confirmed complete resection
Measured: 3 days
Secondary outcomes (5)
Histologically confirmed full thickness resection
Histologically confirmed full thickness resection
Measured: 3 days
Procedure-associated complications
Procedure-associated complications such as bleeding or perforation
Measured: 3 months
Procedure time
Procedure time
Measured: immediate
Necessity of surgical treatment
Measured: 3 months
Residual or recurrent adenoma/carcinoma at endoscopic follow up
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2015 (estimated)
- Study startFeb 2015
- Primary completionFeb 2017 (estimated)
- Study completionFeb 2017 (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 Colorectal AdenomasStudies 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
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kliniken Ludwigsburg-Bietigheim gGmbH
- Sponsor type
- University, hospital or other
- Collaborators
- Ovesco Endoscopy AG
- Responsible party
- Sponsor
- Investigators
- Karel Caca, MD, PhD, Study chair, Klinikum Ludwigsburg, Department of GastroenterologyArthur R Schmidt, MD, Principal investigator, Klinikum Ludwigsburg, Department of Gastroenterology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02362126
- Sponsor's protocol ID
- WALL-RESECT
- Acronym
- WALL-RESECT
- Status last verified
- Feb 2015
- First submitted
- 7 Feb 2015
- Last updated
- 12 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Schurr MO, Baur FE, Krautwald M, Fehlker M, Wehrmann M, Gottwald T, Prosst RL. Endoscopic full-thickness resection and clip defect closure in the colon with the new FTRD system: experimental study. Surg Endosc. 2015 Aug;29(8):2434-41. doi: 10.1007/s00464-014-3923-x. Epub 2014 Oct 16.
PubMed 25318369Schmidt A, Damm M, Caca K. Endoscopic full-thickness resection using a novel over-the-scope device. Gastroenterology. 2014 Oct;147(4):740-742.e2. doi: 10.1053/j.gastro.2014.07.045. Epub 2014 Jul 30. No abstract available.
PubMed 25083605Kuellmer A, Behn J, Beyna T, Schumacher B, Meining A, Messmann H, Neuhaus H, Albers D, Birk M, Probst A, Faehndrich M, Frieling T, Goetz M, Thimme R, Caca K, Schmidt A. Endoscopic full-thickness resection and its treatment alternatives in difficult-to-treat lesions of the lower gastrointestinal tract: a cost-effectiveness analysis. BMJ Open Gastroenterol. 2020 Aug;7(1):e000449. doi: 10.1136/bmjgast-2020-000449.
PubMed 32816955Schmidt A, Beyna T, Schumacher B, Meining A, Richter-Schrag HJ, Messmann H, Neuhaus H, Albers D, Birk M, Thimme R, Probst A, Faehndrich M, Frieling T, Goetz M, Riecken B, Caca K. Colonoscopic full-thickness resection using an over-the-scope device: a prospective multicentre study in various indications. Gut. 2018 Jul;67(7):1280-1289. doi: 10.1136/gutjnl-2016-313677. Epub 2017 Aug 10.
PubMed 28798042
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endoscopic Full Thickness Resection in the Lower GI Tract With the "Full Thickness Resection Device"- A Prospective Multicenter Trial
- ClinicalTrials.gov ID
- NCT02362126
- Acronym / sponsor ID
- WALL-RESECT / WALL-RESECT
- Conditions
- Colorectal Adenomas, Submucosal Tumors
- Keywords
- Endoscopic full thickness resection, EFTR, FTRD, OTSC
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Kliniken Ludwigsburg-Bietigheim gGmbHUniversity, hospital or other
- Collaborators
- Ovesco Endoscopy AG
- Study start
- Feb 2015
- Primary completion
- Feb 2017 (estimated)
- Study completion
- Feb 2017 (estimated)
- First posted
- 12 Feb 2015 (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.
Observational prospective multicenter study to investigate efficacy and safety of endoscopic full thickness resection in the lower GI tract using a novel over-the-scope full thickness resection device.
Detailed description
The FTRD ("Full Thickness Resection Device", Ovesco Endoscopy, Tübingen, Germany) is an over the scope device consisting of a transparent cap with a preloaded monofilament snare and and a 14 mm modified Over-the-scope Clip. The device is CE marked for full thickness resection in the lower GI tract.
The study was designed to investigate efficacy and safety of this device for full thickness resection of colorectal lesions.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients undergoing EFTR | – | Device: Endoscopic full thickness resection (EFTR)Patients with non-lifting adenomas, adnomas at difficult anaotomic locations , T1-carcinomas or submucosal colorectal tumors |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with colorectal lesions which are difficult or impossible to resect with conventional endoscopic methods
Key inclusion criteria (6 listed)
- Age > 18 y
- Adenoma with negtive lifting sign
- Adenoma involving or next to a diverticulum
- Adenoma involving or next to the appendical orifice
- T1 carcinoma with indication for endoscopic (re-)resection
Key exclusion criteria (7 listed)
- Lesions >3 cm
- T1 carcinomas with known high-risk features (submucosal infiltration>1000 um, invasion of lymphatic vessels, poor differentiation (G3))
- Lesions in the upper GI tract
- Patients with colorectal stenosis
- Patinets not able to undergo informed consent
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 full thickness resection (EFTR)Patients undergo EFTR using the FTRD | Device | Patients undergoing EFTR |
Primary outcome
Technical success
Time frame: Immediate
Successful enbloc- and macroscopically complete resection
R0-Resection
Time frame: 3 days
Histologically confirmed complete resection
5 secondary outcomes
Histologically confirmed full thickness resection
Time frame: 3 days
Procedure-associated complications
Time frame: 3 months
Procedure time
Time frame: immediate
Necessity of surgical treatment
Time frame: 3 months
Residual or recurrent adenoma/carcinoma at endoscopic follow up
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2015.
- Background: PubMed 25318369Schurr MO, Baur FE, Krautwald M, Fehlker M, Wehrmann M, Gottwald T, Prosst RL. Endoscopic full-thickness resection and clip defect closure in the colon with the new FTRD system: experimental study. Surg Endosc. 2015 Aug;29(8):2434-41. doi: 10.1007/s00464-014-3923-x. Epub 2014 Oct 16.
- Background: PubMed 25083605Schmidt A, Damm M, Caca K. Endoscopic full-thickness resection using a novel over-the-scope device. Gastroenterology. 2014 Oct;147(4):740-742.e2. doi: 10.1053/j.gastro.2014.07.045. Epub 2014 Jul 30. No abstract available.
- Derived from this study: PubMed 32816955Kuellmer A, Behn J, Beyna T, Schumacher B, Meining A, Messmann H, Neuhaus H, Albers D, Birk M, Probst A, Faehndrich M, Frieling T, Goetz M, Thimme R, Caca K, Schmidt A. Endoscopic full-thickness resection and its treatment alternatives in difficult-to-treat lesions of the lower gastrointestinal tract: a cost-effectiveness analysis. BMJ Open Gastroenterol. 2020 Aug;7(1):e000449. doi: 10.1136/bmjgast-2020-000449.
- Derived from this study: PubMed 28798042Schmidt A, Beyna T, Schumacher B, Meining A, Richter-Schrag HJ, Messmann H, Neuhaus H, Albers D, Birk M, Thimme R, Probst A, Faehndrich M, Frieling T, Goetz M, Riecken B, Caca K. Colonoscopic full-thickness resection using an over-the-scope device: a prospective multicentre study in various indications. Gut. 2018 Jul;67(7):1280-1289. doi: 10.1136/gutjnl-2016-313677. Epub 2017 Aug 10.
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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.
Karel Caca, MD, PhD study chair
Klinikum Ludwigsburg, Department of Gastroenterology
Arthur R Schmidt, MD principal investigator
Klinikum Ludwigsburg, Department of Gastroenterology
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 Colorectal Adenomas and Submucosal Tumors, 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 6 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 12 Feb 2015. 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?
Contact Arthur R Schmidt, MD (0049 (0) 7141 99 67201, arthur.schmidt@kliniken-lb.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Technical success (time frame: Immediate). The study lists 2 primary outcomes in all. 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 NCT02362126, 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 12 Feb 2015.