Multi-Center Study of the NDO Surgical Plicator Utilizing Multiple Implants for the Treatment of GERD

GERD Clinical Trial

Official title:

Multi-Center Study of the NDO Surgical Plicator Utilizing Multiple Implants

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00586859
• Other study ID #: 135-02420
• Status: Terminated
• Phase: N/A
• First received: December 21, 2007
• Last updated: May 29, 2008
• Start date: May 2006
• Est. completion date: October 2007

Study information

• Verified date: May 2008
• Source: NDO Surgical, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 41
• Est. completion date: October 2007
• Est. primary completion date: October 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• GERD

Intervention

Device:
• NDO Full-thickness Plicator
The Plicator and gastroscope assembly were passed into the stomach. The stomach was distended with air. The gastroscope was advanced and retroflexed so that the instrument could be visualized and accurately positioned. The Plicator was retroflexed to within 1cm below the GE junction, and the helical tissue retractor was advanced deeply into the gastric wall. The gastric wall was retracted into the Plicator instrument arms. The arms were then closed, and the suture-implant was deployed to secure the full-thickness plication. The tissue retractor is then disengaged and the suture-implant released from the instrument. Additional sutures were placed in the same manner described above, with each additional implant placed incrementally closer to the GE junction in a linear configuration along the anterior gastric cardia. All plications were placed de novo, and re-treatment was not permitted.

Locations

Country	Name	City	State
Germany	Evangelisches Krankenhaus	Dusseldorf
Germany	Markus-Krankenhaus	Frankfurt
Germany	Medizinische Klinik und Poliklinik Universitatsklinikum Leipzig	Leipzig
Germany	Klinikum Ludwigsburg	Ludwigsburg

Sponsors (1)

Lead Sponsor	Collaborator
NDO Surgical, Inc.

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	GERD Health Related Qualify of Life (HRQL) questionnaire at 6-months post-treatment		1, 6, 12, 24, 36, 48 and 60-month post-treatment	No
Secondary	Heartburn Score		1, 6, 12, 24, 36, 48 and 60-months post-treatment	No
Secondary	Regurgitation score		1, 6, 12, 24, 36, 48 and 60-months post-treatment	No
Secondary	GERD symptom improvement as measured by a visual analog scale		1, 6, 12. 24, 36, 48 and 60-months post-treatment	No
Secondary	GERD medication use		1, 6, 12, 24, 36, 48 and 60-months post-treatment	No
Secondary	Esophageal acid exposure		6-months post-treatment	No
Secondary	Esophageal sphincter (LES) resting pressure as measure by manometry		6-months post-treatment	No
Secondary	Esophagitis score		6-months post-treatment	No