The Performance of the SOLTIVE Laser System for Laser Lithotripsy in Kidney or Ureteral Stones

• Sponsor: Olympus Corporation of the Americas (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT04556201
• Collaborator: (none)
• Enrollment: 450
• Locations: 7
• Arm: 1
• Anticipated Duration (Months): 23
• Patients Per Site: 64.3
• Patients Per Site Per Month: 2.8

Study Details

Study Description

Brief Summary

The purpose of this study is to collect real-world evidence on the performance of the SOLTIVE™ Premium SuperPulsed Laser System for laser lithotripsy in ureteroscopy, percutaneous nephrolithotomy (PCNL) and mini PCNL for kidney and ureteral stones.

Condition or Disease	Intervention/Treatment	Phase
Kidney Stone; Ureteral Stone	Device: SOLTIVE™ Premium SuperPulsed Laser Fiber System	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 450 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Prospective, Multicenter, Post-Market Clinical Registry to Collect Real-World Evidence on the Clinical Performance of the SOLTIVE™ Laser for Treatment of Kidney or Ureteral Stones
• Actual Study Start Date: Dec 1, 2020
• Anticipated Primary Completion Date: Oct 1, 2022
• Anticipated Study Completion Date: Oct 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Thulium Fiber Laser lithotripsy Subjects who have a medical indication for ureteroscopy, percutaneous nephrolithotomy (PCNL) or mini PCNL	Device: SOLTIVE™ Premium SuperPulsed Laser Fiber System; SOLTIVE™ SuperPulsed Laser Fiber System and SOLTIVE™ Laser Fibers for single-use only

Outcome Measures

Primary Outcome Measures

1. Stone free rate [3 month]

   Stone free rate as determined by standard of care imaging

Secondary Outcome Measures

1. Total laser energy time [During procedure]

   Measured from first to last footswitch press in minutes

2. Total procedure time [During procedure]

   Measured from time of initial ureteroscope insertion to time of ureteroscope withdrawal in minutes

3. Accessory devices used [During procedure]

   Types of accessory devices used during the procedure (ureteroscopy, PCNL or mini-PCNL) and the total time used during the procedure in minutes

4. Adverse events [At procedure, immediate post-procedure, 1 month follow-up and 3 month follow-up]

   AEs related to device or procedure and non-serious AEs related to device or procedure

5. Device deficiencies [During procedure]

   Number of device deficiencies during the procedure

6. Rate of treatment/interventions needed [At 1 month follow-up and 3 month follow-up]

   Types of treatments and/or interventions needed post-procedure at the follow-up visits and the number of times treatments and/or interventions were performed

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

1. ≥18 years of age

2. Medical indication for ureteroscopy, percutaneous nephrolithotomy (PCNL) or mini PCNL

3. Willing and able to provide informed consent

4. Female and of childbearing age with a negative pregnancy test

Exclusion Criteria:

1. Contraindicated for uteroscopy, PCNL or mini PCNL as determined by the physician

2. Inability to tolerate anesthesia for any reason

3. Unable or unwilling to provide informed consent

4. Concurrently participating in another competing clinical study

5. Known ureteral stricture

6. Unwilling or unable to return for follow-up

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mayo Clinic Arizona	Phoenix	Arizona	United States	85054
2	Loma Linda University Medical Center	Loma Linda	California	United States	92354
3	Kansas University Medical Center	Kansas City	Kansas	United States	66160
4	Mount Sinai West	New York	New York	United States	10029
5	Ohio State Wexner Medical Center	Columbus	Ohio	United States	43212
6	University Southern Denmark	Fredericia		Denmark	7000
7	Hospital CUF Descobertas	Lisboa		Portugal	1998-018

Sponsors and Collaborators

• Olympus Corporation of the Americas

Investigators

• Principal Investigator: Ben Chew, MD, University of British Columbia
• Principal Investigator: Olivier Traxer, MD, Tenon Hospital, Sorbonne University, Paris

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Olympus Corporation of the Americas
• ClinicalTrials.gov Identifier: NCT04556201
• Other Study ID Numbers: 2020-URO-01
• First Posted: Sep 21, 2020
• Last Update Posted: Jun 22, 2022
• Last Verified: Jun 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: Kidney Calculi; Ureteral Calculi; Ureterolithiasis; Calculi

Study Results

No Results Posted as of Jun 22, 2022