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|
| General |
| Study Status |
Terminated |
Application Number /
Requirement Number |
P020006 / PAS001 |
| Date Original Protocol Accepted |
12/27/2007
|
| Date Current Protocol Accepted |
12/27/2007
|
| Study Name |
Enteryx
|
| Device Name |
ENTERYX PROCEDURE KIT
|
| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
|
| Data Source |
New Data Collection
|
| Comparison Group |
Objective Performance Criterion
|
| Analysis Type |
Descriptive
|
| Study Population |
Transit. Adolescent B (as adults) : 18-21 yrs,
Adult: >21
|
| Detailed Study Protocol Parameters |
| Study Objectives |
The purpose of the post-approval study was to assess the long-term safety and effectiveness of the device, both in subjects undergoing a single treatment and in subjects who are retreated with additional injections of Enteryx. Subjects were enrolled into one of two groups (Part A - new subjects, or Part B -subjects enrolled under the IDE study). The primary effectiveness endpoint was elimination of proton pump inhibitor (PPI) medication use.All subjects would be followed for adverse events, medication injection for three years after the last Enteryx procedure. Subjects enrolled in Part A would also be contacted by the investigational site at least quarterly to obtain current adverse event information.
|
| Study Population |
Study population is as per device indication. This device is indicated for endoscopic injection into the region of the lower esophageal sphincter, for the treatment of gastroesophageal reflux disease (GERD) symptoms in patients responding to and requiring daily pharmacological therapy with proton pump inhibitors.
|
| Sample Size |
A total of 220 patients were enrolled in Part A of the Post-Approval Study. One hundred and sixty nine (169) completed the 12-month visit, 125 completed the 24-month visit and 12 have completed the 36-month visit. Twenty-five (25) patients are either lost to follow-up or have formally withdrawn from the study. One hundred and eighty three (183) patients were active at the time study was terminated. A total of 90 patients were enrolled in Part B of the Post-Approval Study. The 12-month visit was conducted under the IDE, eighty seven (87) patients completed the 24-month visit and 79 completed the 36-month visit. Nine patients are either lost to follow-up or have formally withdrawn from the study.
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| Key Study Endpoints |
The primary effectiveness endpoint was elimination of proton pump inhibitor (PPI) medication use.All subjects would be followed for adverse events, medication injection for three years after the last Enteryx procedure. Subjects enrolled in Part A would also be contacted by the investigational site at least quarterly to obtain current adverse event information.
|
| Follow-up Visits and Length of Follow-up |
Subjects enrolled in Part A would also be contacted by the investigational site at least quarterly to obtain current adverse event information. Total of 3-yearsof follow-up
|
| Interim or Final Data Summary |
| Interim Results |
Study was terminated. See final results
|
| Actual Number of Sites Enrolled |
n/a
|
| Patient Follow-up Rate |
n/a
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| Final Safety Findings |
Since the 2006 FDA report (P020006/R5), there were five new reports of a severe adverse events. All five were Device Related Adverse Events in participants of study Part A. Four cases were in patients that were not retreated or prior to retreatment, and one after retreatment. The severe adverse events included one case of pain retrasternal/chest pain, one case of nausea, one case of vomiting, and two cases of dysphagia/odynophagia. Four cases were resolved and one was ongoing as of report date (2006). In Part B of the study, 7 out of 90 patients had device related AEs including four patients with mild retrosternal/chest pain, dysphagia/odynophagia, fever, epigastric pain/abdominal pain, or heartburn, and 3 patients with moderate dysphagia/odynophagia, nausea, or vomiting.
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| Study Strengths & Weaknesses |
n/a
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| Recommendations for Labeling Changes |
None, product was recalled.
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