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

NCT03186066 | Completed

• 1 other identifier: ESCAPE
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Time for Removal of PEG

  Assessed at day 1 (day of intervention)

Secondary Outcomes (2)

• Success rate

  Assessed at day 1

• Complications

  Assessed during follow-up for up to ten days

Study Arms (2)

Standard Therapy

ACTIVE COMPARATOR

Buried Bumper Syndrome is treated by endoscopically dissecting the overgrown tissue with an endoscopic submucosal dissection knife.

Procedure: Standard Therapy

Flamingo Device

EXPERIMENTAL

The Flamingo device is used for treatment of Buried Bumper Syndrome.

Device: Flamingo Device

Interventions

Flamingo Device DEVICE

Endoscopic Treatment of Buried Bumper Syndrome with the Flamingo Device

Flamingo Device

Standard Therapy PROCEDURE

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

Standard Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Kliniken Ludwigsburg-Bietigheim gGmbH: lead

Study Sites (1)

Klinikum Ludwigsburg

Ludwigsburg, 71640, Germany

Location

Related Publications (1)

• Wannhoff A, Kullmer A, Albers D, Fahndrich M, Ganten T, Wettstein M, Meier B, Schumacher B, Schmidt A, Caca K. Prospective randomized controlled trial comparing a novel and dedicated device with conventional endoscopic techniques for the treatment of buried bumper syndrome (with video). Gastrointest Endosc. 2024 Jan;99(1):23-30.e1. doi: 10.1016/j.gie.2023.07.048. Epub 2023 Aug 3.

  PMID: 37543062 DERIVED

MeSH Terms

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2017
• First Posted: June 14, 2017
• Study Start: June 2, 2017
• Primary Completion: September 30, 2022
• Study Completion: April 8, 2023
• Last Updated: March 12, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)