Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

MOSES Lithotripsy Technology Applied to Stone Fragmentation During Ureteroscopy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03995758
Recruitment Status : Recruiting
First Posted : June 24, 2019
Last Update Posted : June 24, 2019
Sponsor:
Information provided by (Responsible Party):
Amy Krambeck, MD, Indiana University

Brief Summary:
To determine if the effects of MOSES laser modulation technology can improve the safety and efficiency to laser fragmentation resulting in decreased total laser time, reduced potential for injury to the patient, and total OR time and utilization.

Condition or disease Intervention/treatment Phase
Kidney Calculi Device: MOSES Not Applicable

  Show Detailed Description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: The patients will be randomized 1:1 to either standard laser lithotripsy or MOSES laser lithotripsy.
Masking: Single (Investigator)
Masking Description: Surgeons will not be aware of the group assignment.
Primary Purpose: Treatment
Official Title: MOSES Lithotripsy Technology Applied to Stone Fragmentation During Ureteroscopy
Actual Study Start Date : June 6, 2019
Estimated Primary Completion Date : May 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Standard laser lithotripsy
standard of care for stone fragmentation in ureteroscopy
Device: MOSES
software based modulation of the laser energy delivered from the homium laser source. The software changes the pulsed laser to have two peaks of energy - one to displace water in front of the stone and a second to deliver the laser energy to the stone

Active Comparator: MOSES laser lithotripsy
MOSES technology used for stone fragmentation in ureteroscopy
Device: MOSES
software based modulation of the laser energy delivered from the homium laser source. The software changes the pulsed laser to have two peaks of energy - one to displace water in front of the stone and a second to deliver the laser energy to the stone




Primary Outcome Measures :
  1. The primary endpoint of interest will be reduction in total laser time [ Time Frame: Postoperative day 1 ]
    total laser time

  2. The primary endpoint of interest will be reduction in total OR time [ Time Frame: Postoperative day 1 ]
    total surgery time


Secondary Outcome Measures :
  1. Complication rates using Clavien-Dindo score [ Time Frame: 30 days ]

    Clavien Classification of Surgical Complications:

    Grade I: Any deviation from the normal post-operative course without the need for pharmacological treatment or surgical, endoscopic, and radiological interventions.

    Allowed therapeutic regimens are: drugs as antiemetics, antipyretics, analgesics, diuretics, electrolytes, and physiotherapy. This grade also includes wound infections opened at bedside.

    Grade II: Requiring pharmacological treatment with drugs other than such allowed for Grade I complications. Blood transfusions and total parenteral nutrition are also included.

    Grade III: Requiring surgical, endoscopic or radiological intervention. Grade IIIa: Intervention not under general anesthesia Grade IIIb: Intervention under general anesthesia Grade IV: Life-threatening complication (including CNS complications) requiring IC/ICU management.

    Grade IVa: Single organ dysfunction (including dialysis) Grade IVb: Multi-organ dysfunction Grade V: Death of a patient




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • >18 years of age
  • Kidney or ureteral stone requiring laser lithotripsy fragmentation

Exclusion Criteria:

  • < 18 years of age
  • Infectious, struvite stones.
  • Atypical collecting system anatomy that prolongs the case (ureteral stricture, malrotated kidney, infundibular stenosis, ureteral duplication)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03995758


Locations
Layout table for location information
United States, Indiana
Indiana University Health Physicians Urology Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Amy E Krambeck, MD    317-962-3700    akrambeck@iuhealth.org   
Contact: Christa E Stoughton    3179620870    cstoughton@iuhealth.org   
Sponsors and Collaborators
Indiana University

Layout table for additonal information
Responsible Party: Amy Krambeck, MD, Principal Investigator, Indiana University
ClinicalTrials.gov Identifier: NCT03995758     History of Changes
Other Study ID Numbers: 1901990102
First Posted: June 24, 2019    Key Record Dates
Last Update Posted: June 24, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Kidney Calculi
Nephrolithiasis
Calculi
Pathological Conditions, Anatomical
Kidney Diseases
Urologic Diseases
Urolithiasis
Urinary Calculi