Endoscopic Implantation of Enteryx for the Treatment of GERD

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2006 by Beth Israel Deaconess Medical Center.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier:
NCT00346905
First received: June 29, 2006
Last updated: March 19, 2008
Last verified: June 2006
  Purpose

The study objective is to assess the long term safety and effectiveness of Enteryx device in commercial use. The long-term effects beyond one year of treatment with Enteryx have not been established.


Condition Intervention
Gastroesophageal Reflux
Drug: Enteryx

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Endoscopic Implantation of Enteryx for the Treatment of Gastroesophageal Reflux Disease (GERD): Post Market Study

Resource links provided by NLM:


Further study details as provided by Beth Israel Deaconess Medical Center:

Primary Outcome Measures:
  • At 12, 24 and 36 months, the proportion of patients exhibiting clinically significant reduction of
  • PPI medication usage will be > 50% as compared to baseline in both singly treated and retreated
  • patients. A "clinically significant reduction" is defined as either elimination of PPI therapy or
  • reduction in dosage of ≥50%. A reduction in treatment from PPI at any dose to H2 blockers or
  • antacids is considered 100% reduction.

Estimated Enrollment: 300
Study Start Date: October 2003
Estimated Study Completion Date: February 2008
Detailed Description:

The Enteryx procedure kit is indicated for endoscopic injection into the region of the lower esophageal sphincter (LES) for the treatment of symptoms due to gastroesophageal reflux disease (GERD) symptoms in patients responding to and requiring daily pharmacological therapy with proton pump inhibitors (PPI's).

The study design consists of two parts, Part A and Part B. Part A will enroll patients who received Enteryx treatments after approval and Part B will enroll patients previously enrolled and treated in the IDE study #G000065. In total there will be at least 300 patients enrolled in Part A and Part B with 36 months of follow-up Part A: Approximately 150 to 200 patients will be enrolled from 22 centers. After patients have determined with their physicians that Enteryx is an appropriate course of therapy for their GERD symptoms, they will be asked to participate in this trial. Patients will be followed for adverse events, medication use, and GERD-HRQL symptoms at baseline, day of treatment, one month, six months, twelve months, twenty-four months, and thirty-six months. The final study visit will be thirty-six months after the last Enteryx injection. In addition, all Part A patients will be contacted by the Site at least quarterly to obtain current adverse event information. This adverse event information will be solicited from the Site by the Sponsor at least quarterly. Part B: All US IDE patients (approximately 150 patients) will be asked to enroll. Patients will be followed for adverse events, medication use, and GERD-HRQL symptoms at two visits beyond the follow-up prescribed in the IDE study, namely 24 and 36 months after the last Enteryx injection received in the IDE study. Parts A and B: There will be a breakdown of adverse events based on retreatment status. Any subsequent procedures or interventions related to GERD or Enteryx, whether surgical (such as fundoplication) or non-surgical (such as an alternative endoscopic treatment for GERD), will be collected and reported.

H0: (Null hypothesis): Proportion of patients exhibiting clinically significant improvement in reduction of PPI therapy ≤ 0.5

Ha: (Alt. hypothesis): Proportion of patients exhibiting clinically significant improvement in reduction of PPI therapy > 0.5

The Sponsor will examine the proportion of patients who have clinically significant reduction in PPI therapy at the 12, 24 and 36 month follow-ups, in an identical manner to that used for the patients in the IDE trial. The "clinically significant reduction" is defined as either elimination of medication use or reduction in dosage of ≥50%. The criterion for success is defined as more than half of patients demonstrating this degree of medication reduction. The hypothesis is tested by p-value and construction of the exact 95% Clopper-Pearson confidence intervals around the observed proportion of patients who meet the criterion for success. The longitudinal post-procedure follow-up data across time (repeated measures) will be analyzed to determine patterns and trends for all primary endpoints. The hypothesis stated above will also be evaluated in the subset of patients that underwent retreatment prior to amendment v.14Oct05.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • GERD responsive to and requiring daily PPI therapy

Exclusion Criteria:

  • Esophageal varices, particularly related to portal hypertension • Patients whom the physician determines to be a poor candidate for endoscopic procedures and/or anesthesia.

Patients must also be willing to allow their data to be shared with the Sponsor and FDA.

  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: NCT00346905

Locations
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
Investigators
Principal Investigator: Yang Chen, MD University of Colorado, Denver
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00346905     History of Changes
Other Study ID Numbers: Protocol Number: 320 - 1001
Study First Received: June 29, 2006
Last Updated: March 19, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by Beth Israel Deaconess Medical Center:
GERD
Gastroesophageal Reflux Disease
Reflux
Enteryx

Additional relevant MeSH terms:
Gastroesophageal Reflux
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on August 21, 2014