| CTRI Number |
CTRI/2017/07/008974 [Registered on: 05/07/2017] Trial Registered Prospectively |
| Last Modified On: |
18/02/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A clinical trial to study safety and efficacy of medical device known as "Enhanced Lithotripsy System†that breaks the urinary stones and helps in removing the stones from the urinary system. |
|
Scientific Title of Study
|
Feasibility Study of an Enhanced Lithotripsy System (ELS) in the Treatment of Urinary Stone Disease. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 2017-02, version 1.0, dated 11 May 2017 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Mahesh Ramanlal Desai |
| Designation |
Consultant Urologist |
| Affiliation |
Muljibhai Patel Urological Hospital |
| Address |
Department of Urology
Dr. Virendra Desai Road
Nadiad
Kheda
GUJARAT
387001
India |
| Phone |
91-9824028040 |
| Fax |
91-0268-2520248 |
| Email |
mrdesai@mpuh.org |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sonika Newar |
| Designation |
Medical Monitor |
| Affiliation |
JSS Medical Research India Private Limited |
| Address |
6th Floor, Vatika Mindscapes (Tower B)
Plot 12/2, Sector 27 D
Faridabad
HARYANA
121003
India |
| Phone |
91-800799887 |
| Fax |
91-0129-6613520 |
| Email |
sonika.newar@jssresearch.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shariq Anwar |
| Designation |
Head-Operations |
| Affiliation |
JSS Medical Research India Private Limited |
| Address |
6th Floor, Vatika Mindscapes (Tower B) Plot 12/2, Sector 27D
Faridabad
HARYANA
121003
India |
| Phone |
91-9810979215 |
| Fax |
91-0129-6613520 |
| Email |
shariq.anwar@jssresearch.com |
|
|
Source of Monetary or Material Support
|
| Applaud Medical, Inc.
953 Indiana St
San Francisco, CA 94107 |
|
|
Primary Sponsor
|
| Name |
Applaud Medical Inc |
| Address |
953 Indiana St
San Francisco, CA 94107
|
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| JSS Medical Research India Private Limited |
6th Floor, Vatika Mindscapes (Tower B)
Plot 12/2, Sector 27 D
Faridabad, Haryana-121003, India
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Mahesh Ramanlal Desai |
Muljibhai Patel Urological Hospital |
Ground Floor,
Department of Urology,
Pre-Operative Consultation Area,
Dr. Virendra Desai Road,
Nadiad-387001
Kheda
GUJARAT |
91-9824028040
mrdesai@mpuh.org |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Muljibhai Patel Society for Research in Nephro-Urology Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N20||Calculus of kidney and ureter, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
ELS |
It is intended to fragment kidney stones in patients having Urinary Stone Disease. |
| Comparator Agent |
Not Applicable |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. Individuals presenting with one urinary stone—
apparent on a computed tomography (CT) scan within
the last 14 days.
2. Males and females aged 18 or older will be
included. No preference will be given to gender,
although men have a higher prevalence of stone
disease than women.
3. Capable of giving informed consent, and willing to
have the informed consent process videotaped.
4. Stone size, as estimated by pre-operative CT, with
all dimensions 15 mm or less.
|
|
| ExclusionCriteria |
| Details |
1. Individuals under 18 years of age.
2. Individuals with radiolucent stones.
3. Individuals with stones in the lower pole of
kidney.
4. Individuals not following up in the treating
hospital.
5. Individuals with history of cystinuria.
6. Individuals with urine pH below 5.5.
7. Individuals with untreated urinary tract
infection.
8. Individuals who are not willing to use adequate
method of contraception during the study period.
9. Women who are pregnant, lactating or planning
pregnancy during the study period. Individuals
with a coagulation abnormality or taking
prescription anticoagulants. Aspirin usage will be
discontinued at least 7 days prior to enrollment
at the discretion of the attending physician.
10. Individuals with mobility issues who are unable
to comfortably lie still for up to 30 minutes or
roll from their back to their side.
11. Individuals belonging to a vulnerable group
(pregnant, mentally disabled, physically
disabled, prisoner, etc.).
12. Individuals with a BMI greater than 35.
13. Individuals with ASA score of 3 or greater
general anesthesia risk level
14. Known sensitivity to possible medications used
before, during, or after the ELS procedure,
including but not limited to the following:
sedative agents, general anesthetics, topical
anesthetics, and opioid analgesics.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Safety: Proportion of patients with Serious Device-Related AEs. |
After EOS visit (Day 30 post last ELS treatment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Proportion of patients who are successfully treated following up to two ELS treatments
2. Change in pain score after one ELS treatment-- Pain score at different visits would be compared from baseline visit using paired t test or Wilcoxon signed-rank test (whichever appropriate)
3. Post-Treatment time to passage of stone fragments-- Post-treatment time to passage of stone fragments will be analyzed using Kaplan-Meier time-to-event methods
4. Use and quantity of pain medication |
After EOS visit (Day 30 post last ELS treatment |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
06/07/2017 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None Yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
| This is non-randomized, single-arm, unblinded study. Applaud Medical, Inc. has developed Enhanced Lithotripsy System which is a type of lithotripsy and is intended to help characterize recently developed stone fragmentation methods combining low-intensity extracorporeal acoustic energy sources with acoustic energy focusing (AEF) material placed around the stone. The target patient populations is adult males and females aged 18years or above with urinary stone size upto 15mm or less as estimated by pre-operative CT scan. The study duration is approximately 1 year. Enrollment is expected to take place upto 2 months. Follow up is for 1 Month. On Day 1, 2, 3 & 7 Follow up pain and pain medications to be assessed and AEs are evaluated. On Day-14 follow up, CT scan (non-contrast) to evaluate stone status, including size and location of remaining stone; physical exam; assess for pain and pain medications; evaluate for AEs. 30 days after last ELS procedure: Physical exam; Evaluate for adverse events (AEs); Serum creatinine (to re-assess renal function); Assessment of pain and pain medications; Assessment of AEs. | |