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

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

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.

Study Overview

• Status: Completed
• Conditions: Buried Bumper Syndrome
• Intervention / Treatment: Procedure: Standard Therapy; Device: Flamingo Device

• Study Type: Interventional
• Enrollment (Actual): 52
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Ludwigsburg, Germany, 71640
    • Klinikum Ludwigsburg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard Therapy; Buried Bumper Syndrome is treated by endoscopically dissecting the overgrown tissue with an endoscopic submucosal dissection knife.	Procedure: Standard Therapy; Endoscopic Treatment of Buried Bumper Syndrome with an endoscopic submucosal dissection knife
Experimental: Flamingo Device; The Flamingo device is used for treatment of Buried Bumper Syndrome.	Device: Flamingo Device; Endoscopic Treatment of Buried Bumper Syndrome with the Flamingo Device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Time for Removal of PEG	Assessed at day 1 (day of intervention)

Secondary Outcome Measures

Outcome Measure	Time Frame
Success rate	Assessed at day 1
Complications	Assessed during follow-up for up to ten days

Collaborators and Investigators

• Sponsor: Kliniken Ludwigsburg-Bietigheim gGmbH

Study record dates

Study Major Dates

• Study Start (Actual): June 2, 2017
• Primary Completion (Actual): September 30, 2022
• Study Completion (Actual): April 8, 2023

Study Registration Dates

• First Submitted: June 11, 2017
• First Submitted That Met QC Criteria: June 11, 2017
• First Posted (Actual): June 14, 2017

Study Record Updates

• Last Update Posted (Actual): March 12, 2024
• Last Update Submitted That Met QC Criteria: March 7, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease; Syndrome
• Other Study ID Numbers: Escape

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No