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OpenTrials
Completed

NCT Number: NCT03186066

Endoscopic Treatment of the Buried Bumper Syndrome: Comparison of the Flamingo Device Versus Standard Therapy

Percutaneous endoscopic gastrostomy (PEG) is a method for nutrition delivery for patients with insufficient oral intake. A rare but severe complication of PEG is the Buried Bumper Syndrome (BBS). In BBS the internal fixation device of the PEG migrates along the stoma chanel. The internal fixation disc becomes covered by gastric mucosa, which causes loss of patency, fixation of the PEG and possible leakage around the PEG.

BBS can be treated endoscopically by dissecting the overgrowing tissue with endoscopic submucosal dissection (ESD) knifes. A new and alternative approach is the use of the Flamingo device, which is inserted over the PEG and then is used to radially dissect the overgrowing tissue with a cutting wire.

In this study both methods, the standard method using an ESD knife and the Flamingo device, are compared in a randomized controlled open-label trial. Primary endpoint is the time needed for PEG removal.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Klinikum Ludwigsburg

Ludwigsburg, 71640, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Endoscopy proven Buried Bumper Syndrome
  • PEG or Jet-PEG

Exclusion criteria

  • Major Coagulation disorder
  • Percutaneous endoscopic jejunostomy or use of a ballon fixed device

Treatment and study plan

Flamingo Device

Device

Endoscopic Treatment of Buried Bumper Syndrome with the Flamingo Device

standard therapy

Procedure

Endoscopic Treatment of Buried Bumper Syndrome with an endoscopic submucosal dissection knife

Primary outcomes

  1. Time for Removal of PEG

    Time frame: Assessed at day 1 (day of intervention)

Secondary outcomes

  1. Success rate

    Time frame: Assessed at day 1

  2. Complications

    Time frame: Assessed during follow-up for up to ten days

Sponsors and collaborators

Lead sponsor

Kliniken Ludwigsburg-Bietigheim gGmbH

Other

Registry information

Official study title

A Prospective Randomized Controlled Multicenter Trial for Evaluation of the Flamingo Device in Endoscopic Treatment of the Buried Bumper Syndrome.

Acronym: ESCAPE

Important dates

Study start
2017
Primary completion
2022
Study completion
2023
First posted
Jun 14, 2017
Registry last updated
Mar 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.