Buried Bumper SyndromeESCAPENCT03186066
Endoscopic Treatment of the Buried Bumper Syndrome: Comparison of the Flamingo Device Versus Standard Therapy
A study testing Flamingo Device and Standard Therapy in people with Buried Bumper Syndrome, run by Kliniken Ludwigsburg-Bietigheim gGmbH at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Buried Bumper Syndrome
- What is being tested?
- Flamingo Device and Standard Therapy
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteGermany
- Study dates
- 2 Jun 2017to 8 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Endoscopy proven Buried Bumper Syndrome
- PEG or Jet-PEG
Who cannot join
- Major Coagulation disorder
- Percutaneous endoscopic jejunostomy or use of a ballon fixed device
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Buried Bumper Syndrome
- Being tested
- Flamingo Device, Standard Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flamingo DeviceDevice
Endoscopic Treatment of Buried Bumper Syndrome with the Flamingo Device
Standard TherapyProcedure or surgery
Endoscopic Treatment of Buried Bumper Syndrome with an endoscopic submucosal dissection knife
| Study group | Role | What they receive |
|---|---|---|
| Standard Therapy | Active comparator | Buried Bumper Syndrome is treated by endoscopically dissecting the overgrown tissue with an endoscopic submucosal dissection knife. Receives: Procedure: Standard Therapy |
| Flamingo Device | Experimental | The Flamingo device is used for treatment of Buried Bumper Syndrome. Receives: Device: Flamingo Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time for Removal of PEG
Measured: Assessed at day 1 (day of intervention)
Secondary outcomes (2)
Success rate
Measured: Assessed at day 1
Complications
Measured: Assessed during follow-up for up to ten days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2017
- Study start2 Jun 2017
- Primary completion30 Sep 2022
- Study completion8 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Buried Bumper SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kliniken Ludwigsburg-Bietigheim gGmbH
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03186066
- Sponsor's protocol ID
- ESCAPE
- Acronym
- ESCAPE
- Status last verified
- Mar 2024
- First submitted
- 11 Jun 2017
- Last updated
- 12 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37543062
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Controlled Multicenter Trial for Evaluation of the Flamingo Device in Endoscopic Treatment of the Buried Bumper Syndrome.
- ClinicalTrials.gov ID
- NCT03186066
- Acronym / sponsor ID
- ESCAPE / ESCAPE
- Conditions
- Buried Bumper Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Kliniken Ludwigsburg-Bietigheim gGmbHUniversity, hospital or other
- Study start
- 2 Jun 2017 (actual)
- Primary completion
- 30 Sep 2022 (actual)
- Study completion
- 8 Apr 2023 (actual)
- First posted
- 14 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Therapy | Active comparator | Procedure: Standard TherapyBuried Bumper Syndrome is treated by endoscopically dissecting the overgrown tissue with an endoscopic submucosal dissection knife. |
| Flamingo Device | Experimental | Device: Flamingo DeviceThe Flamingo device is used for treatment of Buried Bumper Syndrome. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Endoscopy proven Buried Bumper Syndrome
- PEG or Jet-PEG
Key exclusion criteria (2 listed)
- Major Coagulation disorder
- Percutaneous endoscopic jejunostomy or use of a ballon fixed device
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Flamingo DeviceEndoscopic Treatment of Buried Bumper Syndrome with the Flamingo Device | Device | Flamingo Device |
| Standard TherapyEndoscopic Treatment of Buried Bumper Syndrome with an endoscopic submucosal dissection knife | Procedure or surgery | Standard Therapy |
Primary outcome
Time for Removal of PEG
Time frame: Assessed at day 1 (day of intervention)
2 secondary outcomes
Success rate
Time frame: Assessed at day 1
Complications
Time frame: Assessed during follow-up for up to ten days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2024.
- Derived from this study: PubMed 37543062Wannhoff 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Flamingo Device and Standard Therapy in people with Buried Bumper Syndrome, run by Kliniken Ludwigsburg-Bietigheim gGmbH at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time for Removal of PEG (time frame: Assessed at day 1 (day of intervention)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03186066, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2024.