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

Buried Bumper Syndrome Clinical Trial

— ESCAPE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03186066
• Other study ID #: ESCAPE
• Status: Completed
• Phase: N/A
• Start date: June 2, 2017
• Est. completion date: April 8, 2023

Study information

• Verified date: March 2024
• Source: Kliniken Ludwigsburg-Bietigheim gGmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: April 8, 2023
• Est. primary completion date: September 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Buried Bumper Syndrome
• Syndrome

Intervention

Device:
• Flamingo Device
Endoscopic Treatment of Buried Bumper Syndrome with the Flamingo Device

Procedure:
• Standard Therapy
Endoscopic Treatment of Buried Bumper Syndrome with an endoscopic submucosal dissection knife

Locations

Country	Name	City	State
Germany	Klinikum Ludwigsburg	Ludwigsburg

Sponsors (1)

Lead Sponsor	Collaborator
Kliniken Ludwigsburg-Bietigheim gGmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time for Removal of PEG		Assessed at day 1 (day of intervention)
Secondary	Success rate		Assessed at day 1
Secondary	Complications		Assessed during follow-up for up to ten days