Clinical trial NCT00586859: Multi-Center Study of the NDO Surgical Plicator Utilizing Multiple Implants for the Treatment of GERD
Official title: Multi-Center Study of the NDO Surgical Plicator Utilizing Multiple Implants
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: GERD
Keywords: Gastroesophageal Reflux Disease (GERD)
NDO Full-thickness Plicator
Plicator
Endoluminal GERD Therapy
Lead sponsor: NDO Surgical, Inc.
Sponsor class: INDUSTRY
First posted: 2008-01-07
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: GERD Health Related Qualify of Life (HRQL) questionnaire at 6-months post-treatment
timeFrame: 1, 6, 12, 24, 36, 48 and 60-month post-treatment
Secondary outcomes:
measure: Heartburn Score
timeFrame: 1, 6, 12, 24, 36, 48 and 60-months post-treatment
measure: Regurgitation score
timeFrame: 1, 6, 12, 24, 36, 48 and 60-months post-treatment
measure: GERD symptom improvement as measured by a visual analog scale
timeFrame: 1, 6, 12. 24, 36, 48 and 60-months post-treatment
measure: GERD medication use
timeFrame: 1, 6, 12, 24, 36, 48 and 60-months post-treatment
measure: Esophageal acid exposure
timeFrame: 6-months post-treatment
measure: Esophageal sphincter (LES) resting pressure as measure by manometry
timeFrame: 6-months post-treatment
measure: Esophagitis score
timeFrame: 6-months post-treatment
Other outcomes:
Locations:
city: Dusseldorf
country: Germany
facility: Evangelisches Krankenhaus
city: Frankfurt
country: Germany
facility: Markus-Krankenhaus
city: Leipzig
country: Germany
facility: Medizinische Klinik und Poliklinik Universitatsklinikum Leipzig
city: Ludwigsburg
country: Germany
facility: Klinikum Ludwigsburg
Study officials:
References: