| CTRI Number |
CTRI/2014/05/004642 [Registered on: 30/05/2014] Trial Registered Prospectively |
| Last Modified On: |
21/07/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Food pipe narrowing caused by consuming corroding substances |
|
Scientific Title of Study
|
A Multi-Center, Prospective, Evaluation of the Use of a Fully Covered Metal Stent (FCMS) for the Treatment of Refractory Benign Esophageal Strictures caused by Ingestion |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 90871111 Ver. AA 25June2013 |
Protocol Number |
| NCT01899300 |
ClinicalTrials.gov |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rakesh Kochhar |
| Designation |
Principal Investigator |
| Affiliation |
Postgraduate Institute of Medical Education and Research, Chandigarh Department of Gastroenterology |
| Address |
Department of Gastroenterology
Sector 12, Chandigarh 160012
Sector 12, Chandigarh 160012
Chandigarh
CHANDIGARH
160012
India |
| Phone |
0172756608 |
| Fax |
017274042 |
| Email |
dr_kochhar@hotmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Rakesh Kochhar |
| Designation |
Principal Investigator |
| Affiliation |
Postgraduate Institute of Medical Education and Research, Chandigarh Department of Gastroenterology |
| Address |
Department of Gastroenterology
Sector 12, Chandigarh 160012
Sector 12, Chandigarh 160012
Chandigarh
CHANDIGARH
160012
India |
| Phone |
0172756608 |
| Fax |
017274042 |
| Email |
dr_kochhar@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Akshay Shah |
| Designation |
Clinical Research Associate |
| Affiliation |
Boston Scientific Corporation |
| Address |
25 Nirmal Park Odhav
Near Karma Gas Agency
Ahmedabad
NA
Ahmadabad
GUJARAT
342414
India |
| Phone |
919879144653 |
| Fax |
|
| Email |
akshay.shah@bsci.com |
|
|
Source of Monetary or Material Support
|
| Boston Scientific India
Building No. 5, Tower A, 8th Floor, Cyber Terraces, DLF Cyber City-Phase 3, Gurgaon 122002, India |
|
|
Primary Sponsor
|
| Name |
Boston Scientific |
| Address |
100 Boston Scientific Way Marlborough, MA 01752 |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Rajesh Gupta MD |
Asian Institute of Gastroenterology |
6-3-661, Somajiguda
Hyderabad - 500 082
Hyderabad
ANDHRA PRADESH |
914023378888
drrajeshgupta98@gmail.com |
| Dr Rakesh Kochhar |
Postgraduate Institute of Medical Education & Research, Chandigarh |
Department of Gastroenterology, PGIMER, Chandigarh 160012 India
Chandigarh
CHANDIGARH |
01722756608
dr_kochhar@hotmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Asian Institute of Gastroenterology |
Approved |
| Dept of Pulmonary Medicine,Postgraduate Institute of Medical Education and Research, Chandigarh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
Patients with refractory benign esophageal strictures caused by caustic ingestion. , (1) ICD-10 Condition: T549||Toxic effects of unspecified corrosive substance, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not Applicable
|
Not Applicable
|
| Intervention |
The WallFlex Esophageal Fully Covered Metal Stent |
Not applicable as this is an implantable device |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Availability of medical history pertaining to dysphagia score prior to and during the preceeding SECSER.
Availability of patient history pertaining to weight prior to and at completion of SECSER.
Benign esophageal stricture caused by caustic ingestion 12 or more weeks prior to enrollment.
Single esophageal stricture or multiple esophageal stricture over a length < 6 cm.
Having completed the SECSER consisting of 3 dilations intended to reach 15 mm each, separated by 2 weeks, followed by 3 dilations intended to reach 15 mm each with steroid injections, separated by 2 weeks. The dilations may be performed using Bougie or balloon dilation at the discretion of the investigator.
Refractory stricture defined as recurrence of stricture with associated dysphagia within 6 months after completion of SECSER.
Dysphagia score of 2 (ability to swallow semi-solid foods), 3 (ability to swallow liquids only) or 4 (unable to swallow liquids) at baseline.
Unable to pass a standard endoscope (approx. 9.8 mm diameter).
Age 18 years or older.
Willing and able to comply with the study procedures and provide written informed consent to participate in the study.
|
|
| ExclusionCriteria |
| Details |
Stricture within 2 cm of the upper esophageal sphincter.
Concomitant Esophageal ulcerations.
Prior esophageal stent placements.
Concurrent gastric and/or duodenal obstruction.
Patients with prior full or partial gastrectomy.
Sensitivity to any components of the stent or delivery system.
Concurrent medical condition that would affect the investigator’s ability to evaluate the patient’s condition or could compromise patient safety.
Participation in a clinical trial evaluating an investigational device within 3 months prior to enrollment in this study.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Clinical Success consisting of stent tolerability and adequate ability to sustain nutrition to 6 months after stent removal.
Stent tolerability defined as completion of planned stent indwell.
Adequate ability to sustatin nutrition defined as absence of dysphagia-related reintervention. |
The proposed duration of the study is approximately 21 months, allowing 12 months for enrollment; 2-3 months of stent indwell plus 6 months after stent removal. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Technical stent placement success defined as the ability to deploy the stent in satisfactory position across the stricture. |
Stent placement procedure |
| Stent removal success defined by the ability to remove the stent endoscopically without serious stent removal related complications. |
Stent removal procedure |
| Patient’s Report on Pain compared to Baseline: Day 2, week 1, week 2, and thereafter every 2 weeks until stent removal. |
Stent placement through removal |
| Change of pain medication intake from Baseline: Day 2, week 1, week 2, and thereafter every 2 weeks until stent removal. |
Stent placement through removal |
| Improvement of dysphagia score compared to Baseline: Day 2, week 1, week 2, and thereafter every 2 weeks until end of study. |
Entire Study |
| Dysphagia score during stent treatment compared to dysphagia score during preceeding Standardized Esophageal Caustic Stricture Endoscopic Treatment Regimen (SECSER). |
Stent placement through removal |
| Quality Of Life (QOL) improvement compared to Baseline: Day 2, week 1, week 2, and thereafter every 2 weeks until end of study. |
Entire Study |
| Occurrence and severity of adverse events related to the stent and/or the stent placement or stent removal procedure and of all serious adverse events throughout the duration of the study. |
Entire Study |
| Time to recurrence of stricture, defined as inability of a normal diameter gastroscope (9.8 mm) to pass the stricture. |
Entire Study |
| Incidence of stent migration with or without related Adverse Events (AE). |
Stent placement through removal |
| Number of reinterventions from enrollment to end of study, excluding the stent placement and stent removal procedures. |
Entire Study |
|
Target Sample Size
Modification(s)
|
Total Sample Size="20"
Sample Size from India="20"
Final Enrollment numbers achieved (Total)= "1"
Final Enrollment numbers achieved (India)="1" |
Phase of Trial
Modification(s)
|
Phase 4 |
Date of First Enrollment (India)
Modification(s)
|
16/04/2015 |
| Date of Study Completion (India) |
26/11/2015 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
26/11/2015 |
|
Estimated Duration of Trial
|
Years="2"
Months="9"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| 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
|
To establish clinical proof of concept of temporary placement of the WallFlexâ„¢ Esophageal Fully Covered Metal Stent (FCMS) for the treatment of refractory benign esophageal strictures caused by caustic ingestion. To collect data in support of a hypothesis required to prospectively document the safety and effectiveness of temporary indwell of the WallFlex Esophageal Fully Covered Metal Stent (FCMS) compared to repeated Bougie Dilation for the treatment of refractory benign esophageal strictures caused by caustic ingestion. |