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

NCT00586859 | Terminated

• 1 other identifier: 135-02420
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 4

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.

Conditions

GERD

Keywords

Gastroesophageal Reflux Disease (GERD); NDO Full-thickness Plicator; Plicator; Endoluminal GERD Therapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• 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

Study Arms (1)

A

EXPERIMENTAL

NDO Full-thickness Plicator Procedure

Device: NDO Full-thickness Plicator

Interventions

NDO Full-thickness Plicator DEVICE

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 The gastric wall was retracted into the Plicator instrument arms.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.

A

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• NDO Surgical, Inc.: lead

Study Sites (4)

Evangelisches Krankenhaus

Düsseldorf, 40217, Germany

Location

Markus-Krankenhaus

Frankfurt, 60431, Germany

Location

Medizinische Klinik und Poliklinik Universitatsklinikum Leipzig

Leipzig, D-04103, Germany

Location

Klinikum Ludwigsburg

Ludwigsburg, 71640, Germany

Location

MeSH Terms

Conditions

Gastroesophageal Reflux

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: December 21, 2007
• First Posted: January 7, 2008
• Study Start: May 1, 2006
• Primary Completion: October 1, 2007
• Study Completion: October 1, 2007
• Last Updated: May 30, 2008

Record last verified: 2008-05

Locations

DE (4)