| CTRI Number |
CTRI/2023/04/051704 [Registered on: 18/04/2023] Trial Registered Prospectively |
| Last Modified On: |
26/08/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of laser and pneumatic energy source to fragment ureteric stone during ureteroscopy |
|
Scientific Title of Study
|
Safety and efficacy of thulium fiber laser versus pneumatic lithotripsy for ureteric stones using semi rigid ureteroscopy |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Abhay Dinkar Mahajan |
| Designation |
Urologist and Kidney Transplant Surgen |
| Affiliation |
Sai Urology Hospital |
| Address |
Sai Urology Hospital,Dept of urology,Vishal Nagar,Gajanan Mandir Road,Opp CADA office, Aurangabad-431005
Aurangabad
MAHARASHTRA
431005
India |
| Phone |
9822321224 |
| Fax |
|
| Email |
drabhaymahajan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrAbhay Dinkar Mahajan |
| Designation |
Urologist and Kidney Transplant Surgen |
| Affiliation |
Sai Urology Hospital |
| Address |
Sai Urology Hospital,Dept of urology,Vishal Nagar,Gajanan Mandir Road,Opp CADA office, Aurangabad-431005
Aurangabad
MAHARASHTRA
431005
India |
| Phone |
9822321224 |
| Fax |
|
| Email |
drabhaymahajan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Rekha Uttam Chavan |
| Designation |
Clinical Research Coordinator |
| Affiliation |
Sai Urology Hospital, Aurangabad |
| Address |
Sai Urology Hospital,Dept of urology,Vishal Nagar,Gajanan Mandir Road,Opp CADA office, Aurangabad-431005
Aurangabad
MAHARASHTRA
431005
India |
| Phone |
8380848962 |
| Fax |
|
| Email |
saiurologyhospital23@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Sai Urology Hospital |
| Address |
Sai Urology Hospital, 1, Vishal Nagar, Gajanan Mandir Road, Opp.CADA office, Aurangabad. 431005 |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 |
| DR Abhay Mahajan |
Sai Urology Hospital |
Sai Urology Hospital, Department of Urology, Seminar room Aurangabad-431005
Aurangabad
MAHARASHTRA |
9822321224
drabhaymahajan@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sai Urology Hospital Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N201||Calculus of ureter, (2) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Ureteroscopy |
To compare the energy sources intraoperatively - Thulium fiber laser versus pneumatic lithotripter, for ureteric stone lithotripsy using semirigid ureteroscope. |
| Intervention |
Ureteroscopy |
Use of semirigid ureteroscope for the treatment of ureteric stone along with stone lithotripsy |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
All sexes with age ranging from 5- 75 years
Patients having clinical and radiological diagnosis of ureteric calculi |
|
| ExclusionCriteria |
| Details |
Pregnancy
Coagulopathy
Pyonephrosis
Combined renal and ureteric stone |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Safety and efficacy of Thulium fiber laser versus pneumatic lithotripsy |
Baseline, 7 days, 30 days, 180 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Immediate and long term complications |
6 months |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "100"
Final Enrollment numbers achieved (India)="100" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
20/04/2023 |
| Date of Study Completion (India) |
04/07/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NA |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Thulium fiber laser is a novel technology used for stone lithotripsy. Because of it’s excellent dusting properties it has the potential to become ideal laser for stone treatment. There is a concern of heat generation and potential trauma to the renal and ureteral mucosa during the use of lasers in renal and ureteral stone treatment. Special concern is for the ureteric stone as the lumen is narrow and the stones are usually impacted. Pneumatic lithotripsy is the standard energy source used for ureteral stone treatment. We hence propose to evaluate the Safety and efficacy of thulium fiber laser versus Pneumatic Lithotripsy for ureteric stones using semi rigid ureteroscopy
Primary Objective: Safety & efficacy of laser and pneumatic energy source
Secondary Objective: Immediate & long term complications |