Ignite Creation Date:
2024-05-05 @ 4:56 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00346905
Status:
COMPLETED
Last Update Posted:
2017-07-21
First Post:
2006-06-29
Brief Title:
Endoscopic Implantation of Enteryx for the Treatment of GERD
Sponsor:
Beth Israel Deaconess Medical Center
Organization:
Beth Israel Deaconess Medical Center
Study Overview
Official Title:
Endoscopic Implantation of Enteryx for the Treatment of Gastroesophageal Reflux Disease GERD Post Market Study
Status:
COMPLETED
Status Verified Date:
2017-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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 PPIs
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 05
Ha Alt hypothesis Proportion of patients exhibiting clinically significant improvement in reduction of PPI therapy 05
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 v14Oct05
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 05
Ha Alt hypothesis Proportion of patients exhibiting clinically significant improvement in reduction of PPI therapy 05
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 v14Oct05
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None