| CTRI Number |
CTRI/2024/10/075015 [Registered on: 09/10/2024] Trial Registered Prospectively |
| Last Modified On: |
23/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [ESWL] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A comparative analysis of renal stone clearance rates based on varying time intervals between multiple sessions of extracorporeal shockwave lithotripsy. |
|
Scientific Title of Study
|
A comparative study of renal stone clearance rates following different time intervals between multiple sessions of extra-corporeal shockwave lithotripsy |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Biswajeet Sarmah |
| Designation |
Senior Resident |
| Affiliation |
Department of Urology and Renal Transplant, VMMC and Safdarjung Hospital |
| Address |
Department of Urology and Renal Transplant, VMMC and Safdarjung Hospital
South
DELHI
110029
India |
| Phone |
9101462653 |
| Fax |
|
| Email |
drbiswajeetsarmah09@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sandeep Kumar |
| Designation |
Professor |
| Affiliation |
Department of Urology and Renal Transplant, VMMC and Safdarjung Hospital |
| Address |
Department of Urology and Renal Transplant, VMMC and Safdarjung Hospital
South
DELHI
110029
India |
| Phone |
8447209729 |
| Fax |
|
| Email |
kumarsandeep98@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Biswajeet Sarmah |
| Designation |
Senior Resident |
| Affiliation |
Department of Urology and Renal Transplant, VMMC and Safdarjung Hospital |
| Address |
Department of Urology and Renal Transplant, VMMC and Safdarjung Hospital
South
DELHI
110029
India |
| Phone |
9101462653 |
| Fax |
|
| Email |
drbiswajeetsarmah09@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Urology and Renal Transplant, VMMC and Safdarjung Hospital |
|
|
Primary Sponsor
|
| Name |
Department of Urology and Renal Transplant |
| Address |
VMMC and Safdarjung Hospital, New Delhi -- 110029, India. |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Biswajeet Sarmah |
VMMC and Safdarjung Hospital |
Department of Urology and Renal Transplant, VMMC and Safdarjung Hospital, New Delhi -- 110029
South
DELHI |
9101462653
drbiswajeetsarmah09@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, VMMC and SJH |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N200||Calculus of kidney, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
ESWL |
Stone free clearance rates at 1 week between sessions of ESWL |
| Comparator Agent |
ESWL |
Stone free clearance rates at 3 weeks between sessions of ESWL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Adult patients with renal stones (pelvic stones/pelvic stones extending into a single renal calyx) in normally excreting kidneys; requiring at least two sessions of ESWL. |
|
| ExclusionCriteria |
| Details |
Contraindications to ESWL, history of previous treatment for the same renal stone or stones, congenital renal anomalies and solitary functioning kidney, pediatric patients, age less than 18 years, stones resolving after one session of ESWL, allergy history to contrast agents |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare the stone clearance rates after multiple ESWL sessions in two groups of patients
with different time intervals i.e. 7 days and 21 days.
|
7 days and 21 days.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the morbidity (e.g. pain, hematuria, fever) in patients in both groups. |
1 week after each session of ESWL. |
|
|
Target Sample Size
|
Total Sample Size="160"
Sample Size from India="160"
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
18/10/2024 |
| 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="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
What is the renal stone clearance rate after ESWL in two groups of patients, with one group having an interval of one week between multiple sessions and the other group having an interval of three weeks between multiple sessions?
We hypothesize that an interval of one week between multiple sessions of ESWL is as effective as compared to an interval of three weeks between multiple ESWL sessions, with respect to renal stone clearance rates. |