Endoscopic Treatment of the Buried Bumper Syndrome: Comparison of the Flamingo Device Versus Standard Therapy (ESCAPE)
Primary Purpose
Buried Bumper Syndrome
Status
Unknown status
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Flamingo Device
Standard Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Buried Bumper Syndrome
Eligibility Criteria
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
Sites / Locations
- Klinikum LudwigsburgRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Standard Therapy
Flamingo Device
Arm Description
Buried Bumper Syndrome is treated by endoscopically dissecting the overgrown tissue with an endoscopic submucosal dissection knife.
The Flamingo device is used for treatment of Buried Bumper Syndrome.
Outcomes
Primary Outcome Measures
Time for Removal of PEG
Secondary Outcome Measures
Success rate
Complications
Full Information
NCT ID
NCT03186066
First Posted
June 11, 2017
Last Updated
June 11, 2017
Sponsor
Kliniken Ludwigsburg-Bietigheim gGmbH
1. Study Identification
Unique Protocol Identification Number
NCT03186066
Brief Title
Endoscopic Treatment of the Buried Bumper Syndrome: Comparison of the Flamingo Device Versus Standard Therapy
Acronym
ESCAPE
Official Title
A Prospective Randomized Controlled Multicenter Trial for Evaluation of the Flamingo Device in Endoscopic Treatment of the Buried Bumper Syndrome.
Study Type
Interventional
2. Study Status
Record Verification Date
June 2017
Overall Recruitment Status
Unknown status
Study Start Date
June 2, 2017 (Actual)
Primary Completion Date
September 2019 (Anticipated)
Study Completion Date
October 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kliniken Ludwigsburg-Bietigheim gGmbH
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Buried Bumper Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
64 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Standard Therapy
Arm Type
Active Comparator
Arm Description
Buried Bumper Syndrome is treated by endoscopically dissecting the overgrown tissue with an endoscopic submucosal dissection knife.
Arm Title
Flamingo Device
Arm Type
Experimental
Arm Description
The Flamingo device is used for treatment of Buried Bumper Syndrome.
Intervention Type
Device
Intervention Name(s)
Flamingo Device
Intervention Description
Endoscopic Treatment of Buried Bumper Syndrome with the Flamingo Device
Intervention Type
Procedure
Intervention Name(s)
Standard Therapy
Intervention Description
Endoscopic Treatment of Buried Bumper Syndrome with an endoscopic submucosal dissection knife
Primary Outcome Measure Information:
Title
Time for Removal of PEG
Time Frame
Assessed at day 1 (day of intervention)
Secondary Outcome Measure Information:
Title
Success rate
Time Frame
Assessed at day 1
Title
Complications
Time Frame
Assessed during follow-up for up to ten days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Karel Caca, Prof.
Phone
07141-99
Ext
67201
Email
karel.caca@kliniken-lb.de
First Name & Middle Initial & Last Name or Official Title & Degree
Andreas Wannhoff, Dr.
Phone
07141-99
Ext
67201
Email
andreas.wannhoff@kliniken-lb.de
Facility Information:
Facility Name
Klinikum Ludwigsburg
City
Ludwigsburg
ZIP/Postal Code
71640
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karel Caca, Prof.
Phone
07141-99
Ext
67201
Email
karel.caca@kliniken-lb.de
First Name & Middle Initial & Last Name & Degree
Andreas Wannhoff, Dr.
Phone
07141-99
Ext
67201
Email
andreas.wannhoff@kliniken-lb.de
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Endoscopic Treatment of the Buried Bumper Syndrome: Comparison of the Flamingo Device Versus Standard Therapy
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