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

This study has been terminated.
(Sponsoring company ceased business operations.)
Sponsor:
Information provided by:
NDO Surgical, Inc.
ClinicalTrials.gov Identifier:
NCT00586859
First received: December 21, 2007
Last updated: May 29, 2008
Last verified: May 2008
  Purpose

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.


Condition Intervention
GERD
Device: NDO Full-thickness Plicator

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Multi-Center Study of the NDO Surgical Plicator Utilizing Multiple Implants

Resource links provided by NLM:


Further study details as provided by NDO Surgical, Inc.:

Primary Outcome Measures:
  • GERD Health Related Qualify of Life (HRQL) questionnaire at 6-months post-treatment [ Time Frame: 1, 6, 12, 24, 36, 48 and 60-month post-treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Heartburn Score [ Time Frame: 1, 6, 12, 24, 36, 48 and 60-months post-treatment ] [ Designated as safety issue: No ]
  • Regurgitation score [ Time Frame: 1, 6, 12, 24, 36, 48 and 60-months post-treatment ] [ Designated as safety issue: No ]
  • GERD symptom improvement as measured by a visual analog scale [ Time Frame: 1, 6, 12. 24, 36, 48 and 60-months post-treatment ] [ Designated as safety issue: No ]
  • GERD medication use [ Time Frame: 1, 6, 12, 24, 36, 48 and 60-months post-treatment ] [ Designated as safety issue: No ]
  • Esophageal acid exposure [ Time Frame: 6-months post-treatment ] [ Designated as safety issue: No ]
  • Esophageal sphincter (LES) resting pressure as measure by manometry [ Time Frame: 6-months post-treatment ] [ Designated as safety issue: No ]
  • Esophagitis score [ Time Frame: 6-months post-treatment ] [ Designated as safety issue: No ]

Enrollment: 41
Study Start Date: May 2006
Study Completion Date: October 2007
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
NDO Full-thickness Plicator Procedure
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00586859

Locations
Germany
Evangelisches Krankenhaus
Dusseldorf, Germany, 40217
Markus-Krankenhaus
Frankfurt, Germany, 60431
Medizinische Klinik und Poliklinik Universitatsklinikum Leipzig
Leipzig, Germany, D-04103
Klinikum Ludwigsburg
Ludwigsburg, Germany, 71640
Sponsors and Collaborators
NDO Surgical, Inc.
  More Information

No publications provided

Responsible Party: Bruce Gaumond, Associate Director, Clinical Affairs, NDO Surgical
ClinicalTrials.gov Identifier: NCT00586859     History of Changes
Other Study ID Numbers: 135-02420
Study First Received: December 21, 2007
Last Updated: May 29, 2008
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by NDO Surgical, Inc.:
Gastroesophageal Reflux Disease (GERD)
NDO Full-thickness Plicator
Plicator
Endoluminal GERD Therapy

ClinicalTrials.gov processed this record on October 19, 2014