Utilizing Holmium Laser for FURS Renal Stone Lithotripsy Comparing Stone Breaking vs. Stone Dusting Settings

• ClinicalTrials.gov Identifier: NCT02683993
• Recruitment Status: Unknown
• First Posted: February 17, 2016
• Last Update Posted: August 29, 2017
• Sponsor: Lumenis Ltd.
• Information provided by (Responsible Party): Lumenis Ltd.

Tracking Information

• First Submitted Date: January 28, 2016
• First Posted Date: February 17, 2016
• Last Update Posted Date: August 29, 2017
• Study Start Date: February 2016
• Estimated Primary Completion Date: September 2017 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: February 11, 2016)

• Stone Clearance [ Time Frame: Stone clearance based on 1 month follow-up imaging data as compared to baseline ]
  stone clearance will be confirmed by CT or X-Ray at 1 month follow up.
• Duration of catheterization time [ Time Frame: Change from 1 month to baseline ]
  Duration of catheterization will be measured to evaluate treatment efficiency
• Procedure time [ Time Frame: during the procedure ]
  duration of the procedure as an indicator for treatment efficiency.
• Usage of alternative stone extracting devices [ Time Frame: as measured during the procedure ]
  The need of the surgeon to use baskets, forceps or saline flushing to achieve complete stone clearance. This outcome can influence both procedure time and further complication.
• hospital stay [ Time Frame: Change from 1 month to baseline ]
  hospital duration will be measured to evaluate treatment efficiency

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: February 11, 2016)

• Intraoperative Complications [ Time Frame: during the procedure and during 1 month follow up ]
  Intraoperative Complications will be evaluated based on Modified Clavien Classification- Modified Clavien Grading: Grade 1,Grade 2,Grade 3,Grade 3a,Grade 3b,Grade 4,Grade 4a, Grade 4b, Grade 5.
• Visibility during procedure [ Time Frame: during the procedure ]
  clear vision of the stone and organ compartments as reflected via endoscope and video screen.
• Occurrence of retropulsion that interferes with procedure [ Time Frame: during the procedure ]
  The subjective degree of stone movement and migration as a result of the laser treatment that interfere with procedure flow.
• Fiber performance [ Time Frame: during the procedure ]
  The surgeon will evaluate the degree of Fiber flexibility with scope deflection- and any damage to fiber, Fiber durability- deflection without losing energy/ efficiency and any Damage to scope.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Utilizing Holmium Laser for FURS Renal Stone Lithotripsy Comparing Stone Breaking vs. Stone Dusting Settings
• Official Title: Utilizing Holmium Laser for FURS Renal Stone Lithotripsy Comparing Stone Breaking vs. Stone Dusting Settings
• Brief Summary: Twenty (20) subjects presenting with a renal stone and candidates for FURS (flexible ureteroscopic renal surgery) will undergo a single FURS procedure for a kidney stone as part of the study, using the study device. These subjects will be randomized into stone breaking treatment or stone dusting.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Stone Clearance

Intervention

Device: Lumenis Pulse 120H holmium laser system and 200 DFL ball tip fiber

The Lumenis Pulse P120H will be utilized in high and low frequencies according to subjects group allocation.

Study Arms

• Experimental: Stone breaking
  Lithotripsy will be performed using the Lumenis Pulse 120H holmium laser system with low frequency parameters.
  Intervention: Device: Lumenis Pulse 120H holmium laser system and 200 DFL ball tip fiber
• Experimental: Stone dusting
  Lithotripsy will be performed using the Lumenis Pulse 120H holmium laser system with high frequency parameters.
  Intervention: Device: Lumenis Pulse 120H holmium laser system and 200 DFL ball tip fiber

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: February 11, 2016): 20
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: September 2017
• Estimated Primary Completion Date: September 2017 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

1. Subject will be older than 18 years of age

2. Subject was diagnosed with renal calculi meeting the following criteria:

   • Largest stone measures no more than 2cm on a single diameter and is no less than 0.8cm as defined by X-ray or CT.
   • Accumulative stone burden (addition of all stone diameters) is no more than 2.5cm.
3. Subject is a candidate for FURS procedure
4. Subject is willing and has signed the Informed Consent Form

Exclusion Criteria:

1. Subject has undergone a previous treatment for stones in the same kidney
2. Subject requires another, concomitant procedure, other than FURS, to be performed during this treatment session.
3. Female subject is pregnant
4. Concomitant anticoagulant medication that cannot be suspended during surgery

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT02683993
• Other Study ID Numbers: LUM-SBU-VP-15-01
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Lumenis Ltd.
• Study Sponsor: Lumenis Ltd.
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Lumenis Ltd.
• Verification Date: January 2017