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| [ ...Back to search results ] | [ Print-friendly version ] |
| An evaluation of the Medtronic Gatekeeper system in the treatment of subjects with gastro-oesophageal reflux disease (GERD) |
| ISRCTN | ISRCTN41367345 |
| ClinicalTrials.gov identifier | |
| Public title | An evaluation of the Medtronic Gatekeeper system in the treatment of subjects with gastro-oesophageal reflux disease (GERD) |
| Scientific title | |
| Acronym | N/A |
| Serial number at source | NTR343 |
| Study hypothesis |
The Gatekeeper procedure involves the placement of polyacrylonitrile-based hydrogel prostheses into the oesophageal submucosal space of the lower oesophageal sphincter to prevent reflux.
The Gatekeeper Reflux Repair System offers several advantages to using standard surgical repair or other current endoscopic procedures. These advantages include the ability of the clinician to easily place the prostheses, and placement of the prostheses is reversible. The purpose of this investigation is to demonstrate the intended use of the Medtronic Gatekeeper Reflux Repair System to provide symptomatic relief in subjects diagnosed with gastro-oesophageal reflux disease (GERD). |
| Lay summary | |
| Ethics approval | Received from the local medical ethics committee |
| Study design | Multicentre, randomised, single blind, placebo controlled, parallel group trial |
| Countries of recruitment | Netherlands |
| Disease/condition/study domain | Gastro-oesophageal reflux disease (GERD) |
| Participants - inclusion criteria |
1. Subjects must be at least 18 years of age
2. Subjects with documented typical symptoms of GERD 3. Female subjects of child bearing potential must have a negative pregnancy test within 1 week before treatment and must agree to use an effective means of birth control during participation in the study 4. Subjects who show symptomatic improvement on PPI and want to discontinue their GERD medication 5. Subjects who have demonstrated a baseline 24 hour ph greater than 4% time with pH less than 4.0 6. Subjects with a baseline GERD-HRQL heartburn score of less than 11 on PPI and greater than 20 off PPI 7. Subjects who have been informed of the nature of the study and have agreed to its provisions and provided ICF, approved by the Institutional Review Board or Medical Ethics Committee of the respective clinical site |
| Participants - exclusion criteria |
1. Classified in anaesthesia risk group, American Society of Anaesthesiologists (ASA) class III - IV
2. Extensive barret's oesophagus (greater than 2 cm) 3. Oesophagitis (grades III - IV) 4. Complaints of dysphagia 5. Oesophageal strictures 6. Oesophageal or gastric varices 7. Previous history of gastro-oesophageal surgery, anti-reflux procedures, or gastro-oesophageal or gastric cancer 8. Large hiatal hernia (greater than 3 cm) 9. Ineffective oesophageal motility, defined as amplitudes of less than 30 mmHg greater than 50% of the time 10. Diagnosed with morbid obesity (body mass index [BMI] greater than 35 kg/m^2) 11. Immunocompromised subjects (subjects diagnosed with human immunodeficiency virus (HIV), on chronic steroid use or other immunosuppressants, such as Immuran) 12. History of bleeding diathesis or coagulopathy or who will refuse blood transfusions 13. Inability to discontinue anticoagulation therapy 14. Suffered a stroke or transient ischemic neurological attack (TIA) within the past 6 months 15. Experienced a haematologically significant gastrointestinal bleed within the past 6 months 16. Has other medical illness that may cause the subject to be non-compliant with or unable to meet the requirements of the protocol or is associated with limited life expectancy 17. Simultaneously participating in another device or drug study, or who has participated in any clinical trial involving an experimental device within 6 months or experimental drug within 30 days of study entry 18. Unable or unwilling to cooperate with study procedures |
| Anticipated start date | 13/01/2004 |
| Anticipated end date | 12/10/2005 |
| Status of trial | Completed |
| Patient information material | |
| Target number of participants | 144 |
| Interventions | The subjects will be randomised to receive the Endoscopy Gatekeeper prostheses or to the endoscopy sham control group with 96 subjects in the treatment arm and 48 subjects in the sham control arm. At 6 months following the initial implant sham procedure, the blind will be broken for all subjects and those randomised to receive the sham procedure will have the opportunity to receive the Gatekeeper procedure. All subjects will complete Symptom Assessment and Quality of Life questionnaires in the screening procedure and at 6 weeks, 3, 6 12 months and annually until study closure. Upper endoscopy will be performed in the screening procedure and at 3, 6 and 12 months. Oesophageal manometry and 48 hours Bravo pH studies will be performed in the screening procedure and at 6 and 12 months. All subjects must discontinue any PPI therapy at least 7 days prior to study visits. Two weeks after the procedure all subjects will be directed to discontinue their PPI therapy. After discontinuation of PPi's subjects who have persistent symptoms of heartburn or regurgitation may be given anti-reflux medication using the treatment regimen as described in the protocol. |
| Primary outcome measure(s) | Serious device and procedure related adverse device effects (whether anticipated or unanticipated) at six months post-procedure and the subject's associated symptoms of heartburn at six months post-procedure. |
| Secondary outcome measure(s) | Improved oesophageal pH defined as the total percent of time that pH is less than 4 at six months post Gatekeeper procedure as compared to baseline. |
| Sources of funding | Medtronic Gastroenterology/Urology (MGU) (Netherlands) |
| Trial website | |
| Publications | |
| Contact name | Dr A. Lei |
| Address |
Academic Medical Centre
Motility Center, C2 room 311 Meibergdreef 9 |
| City/town | Amsterdam |
| Zip/Postcode | 1105 AZ |
| Country | Netherlands |
| Sponsor | Academic Medical Centre (AMC) (Netherlands) |
| Address |
Department of Endoscopy
Meibergdreef 9 |
| City/town | Amsterdam |
| Zip/Postcode | 1105 AZ |
| Country | Netherlands |
| Sponsor website: | http://www.amc.uva.nl |
| Date applied | 20/12/2005 |
| Last edited | 03/07/2009 |
| Date ISRCTN assigned | 20/12/2005 |
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| © 2012 ISRCTN unless otherwise stated. | |
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