Clinical trial NCT04556201: The Performance of the SOLTIVE Laser System for Laser Lithotripsy in Kidney or Ureteral Stones
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Kidney Stone
Ureteral Stone
Lead sponsor: Olympus Corporation of the Americas
Sponsor class: INDUSTRY
First posted: 2020-09-21
Enrollment: 450
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Stone free rate
timeFrame: 3 month
Secondary outcomes:
measure: Total laser energy time
timeFrame: During procedure
measure: Total procedure time
timeFrame: During procedure
measure: Accessory devices used
timeFrame: During procedure
measure: Adverse events
timeFrame: At procedure, immediate post-procedure, 1 month follow-up and 3 month follow-up
measure: Device deficiencies
timeFrame: During procedure
measure: Rate of treatment/interventions needed
timeFrame: At 1 month follow-up and 3 month follow-up
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Mayo Clinic Arizona
state: Arizona
city: Loma Linda
country: United States
facility: Loma Linda University Medical Center
state: California
city: Kansas City
country: United States
facility: Kansas University Medical Center
state: Kansas
city: New York
country: United States
facility: Mount Sinai West
state: New York
city: Columbus
country: United States
facility: Ohio State Wexner Medical Center
state: Ohio
city: Fredericia
country: Denmark
facility: University Southern Denmark
city: Lisboa
country: Portugal
facility: Hospital CUF Descobertas
Study officials:
affiliation: University of British Columbia
name: Ben Chew, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Tenon Hospital, Sorbonne University, Paris
name: Olivier Traxer, MD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Pasqui F, Dubosq F, Tchala K, Tligui M, Gattegno B, Thibault P, Traxer O. Impact on active scope deflection and irrigation flow of all endoscopic working tools during flexible ureteroscopy. Eur Urol. 2004 Jan;45(1):58-64. doi: 10.1016/j.eururo.2003.08.013.
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