| CTRI Number |
CTRI/2021/05/033627 [Registered on: 17/05/2021] Trial Registered Prospectively |
| Last Modified On: |
13/05/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of Thulium laser fibre Vs Holmium laser fibre for kidney stone for RIRS
|
|
Scientific Title of Study
|
A Comparative study of Thulium laser fibre Vs Holmium laser for kidney stone in RIRS(Retrograde intrarenal surgery):
A Randomised controlled single centre trial
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
aditya parikh |
| Designation |
Resident |
| Affiliation |
MPUH |
| Address |
MPUH Nadiad,
VV Desai Road,
Nadiad
Kheda
GUJARAT
387001
India |
| Phone |
09825061790 |
| Fax |
|
| Email |
adityaparikh26@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
aditya parikh |
| Designation |
Resident |
| Affiliation |
MPUH |
| Address |
MPUH Nadiad,
VV Desai Road,
Nadiad
Kheda
GUJARAT
387001
India |
| Phone |
09825061790 |
| Fax |
|
| Email |
adityaparikh26@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
aditya parikh |
| Designation |
Resident |
| Affiliation |
MPUH |
| Address |
MPUH Nadiad,
VV Desai Road,
Nadiad
Kheda
GUJARAT
387001
India |
| Phone |
09825061790 |
| Fax |
|
| Email |
adityaparikh26@gmail.com |
|
|
Source of Monetary or Material Support
|
| muljibhai urology hospital |
|
|
Primary Sponsor
|
| Name |
muljibhai urology hospital |
| Address |
MPUH Nadiad,
VV Desai Road,
nadiad |
| 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 |
| Aditya Parikh |
MPUH |
Department of Urology,
MPUH Nadiad,
VV Desai Road
387001
Kheda
GUJARAT |
09825061790
adityaparikh26@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Muljibhai Patel Society for research in Nephro-Urology |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N20||Calculus of kidney and ureter, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Holmium Laser in RIRS |
For Renal stones upto 2 cm in size RIRS is an accepted modality. Traditionally Holmium laser was the workhorse laser. However with the advent of the Thulium fiber laser and its proven safety in patients and faster lasing speed in-vitro a comparative study to establish the safer and faster laser is necessary. We will measure stone volume and time required to completely break the stone and compare the rate of stone breakage |
| Intervention |
Thulium laser Fiber in RIRS |
For Renal stones upto 2 cm in size RIRS is an accepted modality. Traditionally Holmium laser was the workhorse laser. However with the advent of the Thulium fiber laser and its proven safety in patients and faster lasing speed in-vitro a comparative study to establish the safer and faster laser is necessary. We will measure stone volume and time required to completely break the stone and compare the rate of stone breakage. |
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
All stones less than 2 cm who will undergo RIRS will be randomised except two mentioned in the exclusion criteria |
|
| ExclusionCriteria |
| Details |
Age less than 18 years
Stone larger than 2 cm
Active infection
Anomalous anatomy
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
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Primary Outcome
|
| Outcome |
TimePoints |
| Comparison of Fragmentation rate |
day 0, 30 day follow up |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Operative time
2.Vision during lasing
3. Stone clearance
4. Complications
5. Total Energy used during procedure
|
Day 0, day of discharge, 1 month follow up |
|
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Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 4 |
|
Date of First Enrollment (India)
|
17/05/2021 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
—Holmium:YAG laser has been the Gold standard in the treatment of upper and lower urinary tract stones. —The SuperPulse Thulium fiber laser is an alternative laser source being studied world over as it is proposed to have lower retropulsion and higher efficiency. — There are quite a few prior experimental studies comparing Holmium:YAG laser and Thulium fiber laser for lithotripsy. Multiple studies reported about a 1.5–4 times faster stone ablation rate in favour of the Thulium laser fiber [1,2,3]. This needs to be tested in the patients. Safety of both lasers has been proven in literature but there are no studies comparing the two lasers |