NCT03186066

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: Kliniken Ludwigsburg-Bietigheim gGmbH · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Buried Bumper Syndrome

Interventions

Type	Name	Description
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

Timeline

• Start date: 2017-06-02
• Primary completion: 2022-09-30
• Completion: 2023-04-08
• First posted: 2017-06-14
• Last updated: 2024-03-12

Locations

1 site across 1 country: Germany