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Comparison of SP TFL and Ho:YAG for RIRS Using 145 µm and 200 µm Fibers

Primary Purpose

Kidney Stone, Nephrolithiasis, Urolithiasis

Status

Unknown status

Phase

Not Applicable

Locations

Russian Federation

Study Type

Interventional

Intervention

SP TFL RIRS with 145 mcm fiber

SP TFL RIRS with 200 mcm fiber

Ho:YAG RIRS with 200 mcm fiber

About this trial

This is an interventional treatment trial for Kidney Stone focused on measuring RIRS, holmium laser, superpulse thulium laser, kidney stone disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Males and Females > 18 y.o.;
Radiologically confirmed (CT) kidney stone;
Stone size from 10 to 20 mm.

Exclusion Criteria:

• Multiple (more than 3) kidney stones > 5 mm

Sites / Locations

Institute for Urology and Reproductive Health, Sechenov University.Recruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Arm Label

SP TFL RIRS with 145 mcm fiber

SP TFL RIRS with 200 mcm fiber

Ho:YAG RIRS with 200 mcm fiber

Arm Description

Superpulse thulium fiber laser RIRS with 145 mcm laser fiber

Superpulse thulium fiber laser RIRS with 200 mcm laser fiber

Ho:YAG laser RIRS with 200 mcm laser fiber

Outcomes

Primary Outcome Measures

Laser-on time

Time of laser emission during surgery, seconds

Secondary Outcome Measures

adverse events

Complications according to Clavien-Dindo classification (higher score means more severe complication)

Operative time

Surgery duration, minutes

Hemoglobin drop

Change of hemoglobin level 1 day after surgery comparing to pre-operative value, g/L

Catheter stay

duration of catheterisation, days

hospitalization length

Duration of hospital stay after surgery, days

Radiation exposure

Duration of X-ray exposure, sec.

Radiation exposure

Effective dose, mSv

Stone-free rate

Percentage of patients with absence of stones larger 3 mm in maximum size on follow-up CT

Full Information

NCT ID

NCT04346485

First Posted

March 12, 2020

Last Updated

July 21, 2021

Sponsor

I.M. Sechenov First Moscow State Medical University

1. Study Identification

Unique Protocol Identification Number

NCT04346485

Brief Title

Comparison of SP TFL and Ho:YAG for RIRS Using 145 µm and 200 µm Fibers

Official Title

Prospective Randomized Comparison of SP TFL and Ho:YAG for RIRS Using 145 µm and 200 µm Fibers for the Management of Lower Pole Kidney Stones: Single-center Study

Study Type

Interventional

2. Study Status

Record Verification Date

July 2021

Overall Recruitment Status

Unknown status

Study Start Date

March 13, 2020 (Actual)

Primary Completion Date

May 31, 2022 (Anticipated)

Study Completion Date

May 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

I.M. Sechenov First Moscow State Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

The authors hypothesize that the RIRS using 150-microm Tm-fiber laser is superior than fiber with larger diameters, as 200-microm Tm-fiber laser or 200-microm holmium fiber laser, in such points as follows: decreasing surgery time and laser-on time due to possibility of 4.3 fold ablation efficacy increase, which has been shown by Andreeva et al.; increasing the flexible ureteroscope tip deflection lower pole stones availability; decreased risk of complications and a better irrigation and visualization due to better irrigation with smaller fiber; increasing of lithotripsy efficacy and laser beam density by lowering of beam focal spot due to using of lesser fiber diameter

Detailed Description

RIRS will be performed with SP TFL or Ho:YAG (100 W). The procedure is performed under general anesthesia with the patient in the dorsal lithotomy position. The bladder is entered either with a cystoscope or a semi-rigid ureterorenoscope. Guidewires (0.035") will be used to facilitate access (under fluoroscopic guidance). After access sheath (12/14) will be placed up to the kidney pelvis. Through the access sheath ureteroscope will be introduced. For nephrolithotripsy 145 mcm and 200 mcm fibers will be used. Large fragments could be extracted with nitinol basket. After the surgery ureteral stent (7 Fr.) will be placed inside the ureter for 10 to 14 days. A 10 Fr urethral catheter can be placed in the bladder for the drainage of the bladder during the operation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Kidney Stone, Nephrolithiasis, Urolithiasis

Keywords

RIRS, holmium laser, superpulse thulium laser, kidney stone disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

105 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

SP TFL RIRS with 145 mcm fiber

Arm Type

Experimental

Arm Description

Superpulse thulium fiber laser RIRS with 145 mcm laser fiber

Arm Title

SP TFL RIRS with 200 mcm fiber

Arm Type

Experimental

Arm Description

Superpulse thulium fiber laser RIRS with 200 mcm laser fiber

Arm Title

Ho:YAG RIRS with 200 mcm fiber

Arm Type

Active Comparator

Arm Description

Ho:YAG laser RIRS with 200 mcm laser fiber

Intervention Type

Procedure

Intervention Name(s)

SP TFL RIRS with 145 mcm fiber

Intervention Description

retrograde intrarenal surgery

Intervention Type

Procedure

Intervention Name(s)

SP TFL RIRS with 200 mcm fiber

Intervention Description

retrograde intrarenal surgery

Intervention Type

Procedure

Intervention Name(s)

Ho:YAG RIRS with 200 mcm fiber

Intervention Description

retrograde intrarenal surgery

Primary Outcome Measure Information:

Title

Laser-on time

Description

Time of laser emission during surgery, seconds

Time Frame

during surgery

Secondary Outcome Measure Information:

Title

adverse events

Description

Complications according to Clavien-Dindo classification (higher score means more severe complication)

Time Frame

during surgery and 6 months after surgery

Title

Operative time

Description

Surgery duration, minutes

Time Frame

during surgery

Title

Hemoglobin drop

Description

Change of hemoglobin level 1 day after surgery comparing to pre-operative value, g/L

Time Frame

1 day after surgery

Title

Catheter stay

Description

duration of catheterisation, days

Time Frame

1 week

Title

hospitalization length

Description

Duration of hospital stay after surgery, days

Time Frame

1 week

Title

Radiation exposure

Description

Duration of X-ray exposure, sec.

Time Frame

during surgery

Title

Radiation exposure

Description

Effective dose, mSv

Time Frame

during surgery

Title

Stone-free rate

Description

Percentage of patients with absence of stones larger 3 mm in maximum size on follow-up CT

Time Frame

3 month

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Males and Females > 18 y.o.; Radiologically confirmed (CT) kidney stone; Stone size from 10 to 20 mm. Exclusion Criteria: • Multiple (more than 3) kidney stones > 5 mm

Facility Information:

Facility Name

Institute for Urology and Reproductive Health, Sechenov University.

City

Moscow

ZIP/Postal Code

119991

Country

Russian Federation

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Dmitry Enikeev, MD

Phone

+7 925 517 79 26

enikeev-dv@1msmu.ru

12. IPD Sharing Statement

Plan to Share IPD

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Comparison of SP TFL and Ho:YAG for RIRS Using 145 µm and 200 µm Fibers

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