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Status unknownNCT02362126WALL-RESECTUpdated Feb 12, 2015

Endoscopic Full Thickness Resection in the Lower GI Tract With the "Full Thickness Resection Device"

An observational study in Colorectal Adenomas and Submucosal Tumors, sponsored by Kliniken Ludwigsburg-Bietigheim gGmbH. Status unknown at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-02-12.

Sponsored by Kliniken Ludwigsburg-Bietigheim gGmbH · Observational

The sponsor has not verified this record recently (last verified Feb 2015), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
80
Ages
18 Years and older
Sex
All
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Study 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 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.

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Conditions studied

  • Colorectal Adenomas
  • Submucosal Tumors

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Keywords

  • Endoscopic full thickness resection
  • EFTR
  • FTRD
  • OTSC
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In context

Adenoma

657 studies on the registry are indexed under Adenoma; 98 are open to participants now.

This study's planned enrollment of 80 is below the median of 300 across 226 observational studies indexed under Adenoma.

Browse Adenoma studies →

Lead sponsor

Kliniken Ludwigsburg-Bietigheim gGmbH is the lead sponsor of 9 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with colorectal lesions which are difficult or impossible to resect with conventional endoscopic methods

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
80 participants (estimated)
Patient registry
No

Groups and cohorts

  • Patients undergoing EFTR

    Patients with non-lifting adenomas, adnomas at difficult anaotomic locations , T1-carcinomas or submucosal colorectal tumors

    Device: Endoscopic full thickness resection (EFTR)

Interventions

  • DeviceEndoscopic full thickness resection (EFTR)

    Patients undergo EFTR using the FTRD

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What researchers measure

Primary outcomes

  1. Technical success

    Successful enbloc- and macroscopically complete resection

    Time frame: Immediate

  2. R0-Resection

    Histologically confirmed complete resection

    Time frame: 3 days

Secondary outcomes

  1. Histologically confirmed full thickness resection

    Histologically confirmed full thickness resection

    Time frame: 3 days

  2. Procedure-associated complications

    Procedure-associated complications such as bleeding or perforation

    Time frame: 3 months

  3. Procedure time

    Procedure time

    Time frame: immediate

  4. Necessity of surgical treatment

    Time frame: 3 months

  5. Residual or recurrent adenoma/carcinoma at endoscopic follow up

    Time frame: 3 months

07

Study locations

1 of 1 sites recruiting
  • Klinikum Ludwigsburg
    Ludwigsburg, Baden-Württemberg 71640, Germany
    Recruiting
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References and documents

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 25318369 ↗
  • Schmidt 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 25083605 ↗
  • Kuellmer 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 32816955 ↗
  • Schmidt 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 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 12, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02362126
Lead sponsor
Kliniken Ludwigsburg-Bietigheim gGmbH
Collaborators
Ovesco Endoscopy AG
Responsible party
Sponsor
First posted
Feb 12, 2015
Start date
Feb 2015
Primary completion
Feb 2017 (estimated)
Completion
Feb 2017 (estimated)
Last update
Feb 12, 2015

Study contacts

Arthur R Schmidt, MD
Contact
arthur.schmidt@kliniken-lb.de
0049 (0) 7141 99 67201
Karel Caca, MD, PhD
Contact
karel.caca@kliniken-lb.de
0049 (0) 7141 99 67201
Karel Caca, MD, PhD
study chair · Klinikum Ludwigsburg, Department of Gastroenterology
Arthur R Schmidt, MD
principal investigator · Klinikum Ludwigsburg, Department of Gastroenterology

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2015. You cannot join it, but the record below documents what was studied.

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