| CTRI Number |
CTRI/2012/05/002687 [Registered on: 23/05/2012] Trial Registered Retrospectively |
| Last Modified On: |
01/09/2014 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of Long-Term Electrical Stimulation on LES Pressure and Esophageal Acid Exposure in Patients With GERD |
|
Scientific Title of Study
|
An Investigation of the Effect of Long-Term Electrical Stimulation on Lower Esophageal Sphincter (LES) Pressure and Esophageal Acid Exposure in Patients with Gastroesophageal Reflux Disease (GERD) |
| Trial Acronym |
NA |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CS005 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr DNageshwar Reddy |
| Designation |
Principal Investigator |
| Affiliation |
Asian Institute of Gastroenterology |
| Address |
6-3-661,
Somajiguda,
Hyderabad.
Rangareddi
ANDHRA PRADESH
500082
India |
| Phone |
040-23378888 |
| Fax |
040-23324255 |
| Email |
aigindiainfo@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr DMRavichand |
| Designation |
Director, Medical Operations |
| Affiliation |
MakroCare Clinical Research Limited |
| Address |
#1-65/2/256, Makro Towers
Kavuri Hills,
Madhapur,
Hyderabad.
Rangareddi
ANDHRA PRADESH
500033
India |
| Phone |
040-4436666 |
| Fax |
040-4436667 |
| Email |
Ravichand.devulach@makrocare.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Yashodara Kancharla |
| Designation |
Clinical Project Manager |
| Affiliation |
MakroCare Clinical Research Limited |
| Address |
#1-65/2/256, Makro Towers
Kavuri Hills, Madhapur
Hyderabad.
Rangareddi
ANDHRA PRADESH
500033
India |
| Phone |
040-4436666 |
| Fax |
040-4436667 |
| Email |
yashoda.kancharl@makrocare.com |
|
|
Source of Monetary or Material Support
|
| Endostim Inc,
4041 Forest Park Ave, Ste.127
St. Louis, Missouri USA 63108
|
|
|
Primary Sponsor
|
| Name |
Endostim Inc |
| Address |
4041 Forest Park Ave, Ste.127
St. Louis, Missouri USA 63108
|
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Not Applicable |
Not Applicable |
|
|
Countries of Recruitment
|
Chile
Colombia
Germany
India
Netherlands |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr D Nageshwar Reddy Department of medical gastroentrology Ground floorOP |
Asian Institute of Gastroenterology |
6-3-661, Somajiguda,
Hyderabad
500082
Rangareddi
ANDHRA PRADESH |
040-23378888
040-23324255
aigindiainfo@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Asian insititue of gastroentrology Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Gastroesophageal Reflux Disease, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Lower Esophageal Sphincter Stimulation System |
Not applicable as this is a Implantable device |
| Comparator Agent |
Not Applicable |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
-Subject is between 21 – 70 years of age.
-Subject has a history of heartburn, regurgitation or both for >12 month prompting physician recommendation of continual daily use of PPI before study entry.
-Baseline GERD HRQL heartburn score ≥ 20 following 10-14 days off PPI and at least 10 points higher than the On PPI score
-Subject who are on standard medical therapy for 12 months or longer and experience discomfort or who are otherwise dissatisfied with GERD symptoms
-Subjects with a GERD condition that in the opinion of the PI justifies a minimally invasive reversible procedure prior to attempting anatomical change such as Nissen Fundoplication
-Subject has an American Society of Anesthesiologists (ASA) Physical Status Classification I or II (or comparable local classification if any).
-Subject has exhibited excessive lower esophageal acid exposure during 24-hour pH-metry of antisecretory therapy performed within 6 months of screening visit; pH < 4 for > 5% of total time.
-Subject has a resting LES end expiratory pressure ≥ 5mm Hg and ≤ 15 mmHg on a high resolution manometry within 6 months of enrollment.
-Subject has esophagitis ≤ Grade C (LA classification) on upper endoscopy within 6 months of enrollment.
-Subject has esophageal body contraction amplitude > 30 mmHg for >50% of swallows and > 50% peristaltic contractions on high resolution manometry.
-Subject has signed the informed consent form and is able to adhere to study visit schedule.
|
|
| ExclusionCriteria |
| Details |
-Subject has any non-GERD esophageal motility disorders.
-Subject has gastroparesis.
-Subject has any significant multisystem diseases.
-Subject has an autoimmune or a connective tissue disorder (e.g. scleroderma, dematomyositis, Calcinosis-Raynaud’s-Esophagus Sclerodactyly Syndrome (CREST), Sjogren’s Syndrome, Sharp’s Syndrome) requiring therapy in the preceding 2 years.
-Subject has Barrett’s epithelium ( M2; C1) or any grade of dysplasia.
-Subject has a hiatal hernia larger than 3 cm.
-Subject has a body mass index (BMI) greater than 35 kg/m2.
-Subject has Type 1 diabetes mellitus
-Subject has uncontrolled Type 2 diabetes mellitus (T2DM) defined as HbA1c 9.5 in the previous 6 months, or has T2DM for 10 years.
-Subject has a history of suspected or confirmed esophageal or gastric cancer.
-Subject has esophageal or gastric varices.
-Subject has significant cardiac arrhythmia or ectopy or significant cardiovascular disease.
-Subject has an existing implanted electrical stimulator (e.g., pacemaker, AICD).
-Subject requires chronic anticoagulant therapy.
-Subject has dysphagia or esophageal peptic stricture, excluding Schatzki’s ring.
-Subject of child-bearing potential who is pregnant or intends to become pregnant during the trial period.
-Subject is currently enrolled in other potentially confounding research.
-History of any malignancy in the last 2 years.
-History of previous esophageal or gastric surgery, including nissen fundoplication.
-Subject has any condition that, at the discretion of the investigator or sponsor, would preclude participation in the trial.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The primary endpoint of the study is safety. Safety will be assessed by the incidence and severity of any complications that are associated with the investigational stimulation device throughout the follow-up period. |
2 week after implant, 1 month after implant, 2 months after implant, 3 month after the implant, 4 month after the implant, 5 month after the implant, 6 month after the implant. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The secondary endpoints are related to efficacy as measured by comparison of the following |
Not Applicable |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="10"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
30/04/2012 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
26/08/2011 |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is a prospective, open label, multicenter, treatment trial to investigate the Effect of Long-Term Electrical Stimulation on Lower Esophageal Sphincter (LES) Pressure and Esophageal Acid Exposure in Patients with Gastroesophageal Reflux Disease (GERD) that will be conducted on 30 patients in 8 countries (Chile, Colombia, Belgium, Germany, The Netherlands, Sweden, and India) over an eight-month period encompassing initiation of enrollment through six months follow up. The primary safety endpoint will be assessed by incidence and severity of adverse events through 6 months follow-up. The secondary efficacy endpoint will be assessed by change in GERD symptoms, Lower Esophageal Sphincter End Expiratory Pressure, and Esophageal Acid Exposure over a period of six months from baseline. |