Multi-Center Study of the NDO Surgical Plicator Utilizing Multiple Implants for the Treatment of GERD
- Conditions
- GERD
- Interventions
- Device: NDO Full-thickness Plicator
- Registration Number
- NCT00586859
- Lead Sponsor
- NDO Surgical, Inc.
- Brief Summary
The purpose of this study was to evaluate the safety and efficacy of placing multiple transmural sutures for the treatment of GERD.
A prospective, multi-center, open-label trial was conducted at four centers in Germany to evaluate a modified Plicator technique for the treatment of patients with symptomatic GERD. Primary efficacy was based on analysis of the GERD Health Related Qualify of Life (HRQL) questionnaire at 6-months post-treatment. Additional efficacy outcomes assessed were heartburn and regurgitation symptoms scores, visual analog scale (VAS) score, GERD medication use, esophageal pH/manometry, and esophagitis. Trial sample size was chosen to provide 87% power in detecting a 50% median reduction in GERD-HRQL score at an alpha level of 0.05.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 41
- Subject is 18 years of age or older.
- History of heartburn or regurgitation for at least 6 months.
- Esophageal manometry study (conducted within the previous 6 months) demonstrating an adequate resting pressure of the lower esophageal sphincter (LES) of at least 5 mm Hg.
- pH study (conducted within the previous 6 months) demonstrating pathological reflux (defined as the total % time of pH<4.0 > 4.5% or a DeMeester composite score > 14.7).
- Symptoms requiring daily PPI therapy.
- GERD-HRQL scores must be > 15 while Off Medication and Off Medication scores must be > 6 points higher than On-Medication scores.
- Subject is a surgical candidate in the event of a complication related to this procedure, Class ASA I or II.
- Subject agrees to participate and signs consent form.
- Patient is pregnant.
- Patient has hiatal hernia > 3 cm.
- Presence of persistent dysphagia, weight loss, esophageal bleeding, vomiting (>1 per week) or gas/bloat.
- Esophagitis grades III or IV by Savary criteria.or type C or D by Los Angeles classification .
- Barrett's esophagus with dysplasia.
- Patient has had a previous endoscopic (Endocinch, Stretta, Enteryx, etc.) or surgical repair (Nissen Fundoplication, etc.) performed to treat GERD.
- Active medical condition that would preclude the subject from finishing this study.
- Abnormal blood coagulation or the chronic use of anticoagulant or platelet anti-aggregation therapy (other than for cardiac prophylaxis).
- Pathological changes in soft tissue that would prevent secure fixation of the EPS Implant.
- Presence of esophageal or gastric varices.
- Esophageal dysmotility as determined by manometry studies.
- Esophageal stricture.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description A NDO Full-thickness Plicator NDO Full-thickness Plicator Procedure
- Primary Outcome Measures
Name Time Method GERD Health Related Qualify of Life (HRQL) questionnaire at 6-months post-treatment 1, 6, 12, 24, 36, 48 and 60-month post-treatment
- Secondary Outcome Measures
Name Time Method Heartburn Score 1, 6, 12, 24, 36, 48 and 60-months post-treatment Regurgitation score 1, 6, 12, 24, 36, 48 and 60-months post-treatment GERD symptom improvement as measured by a visual analog scale 1, 6, 12. 24, 36, 48 and 60-months post-treatment GERD medication use 1, 6, 12, 24, 36, 48 and 60-months post-treatment Esophageal acid exposure 6-months post-treatment Esophageal sphincter (LES) resting pressure as measure by manometry 6-months post-treatment Esophagitis score 6-months post-treatment
Trial Locations
- Locations (4)
Evangelisches Krankenhaus
🇩🇪Dusseldorf, Germany
Klinikum Ludwigsburg
🇩🇪Ludwigsburg, Germany
Medizinische Klinik und Poliklinik Universitatsklinikum Leipzig
🇩🇪Leipzig, Germany
Markus-Krankenhaus
🇩🇪Frankfurt, Germany