Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Feasibility Study of an Enhanced Lithotripsy System in the Treatment of Urinary Stone Disease

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03195920
Recruitment Status : Terminated (Interim data was sufficient for study purpose)
First Posted : June 22, 2017
Last Update Posted : June 27, 2018
Sponsor:
Information provided by (Responsible Party):
Applaud Medical, Inc.

Brief Summary:
This is a single arm, single center study to assess the safety and efficacy of a form of extracorporeal lithotripsy, called the Enhanced Lithotripsy System, to treat urinary stones.

Condition or disease Intervention/treatment Phase
Urinary Stone Device: Enhanced Lithotripsy System Not Applicable

Detailed Description:
This is a single arm, single center study to assess the safety and efficacy of a form of extracorporeal lithotripsy, called the Enhanced Lithotripsy System, to treat urinary stones. Subjects will be treated up to 2 times with the Enhanced Lithotripsy System and followed for 30 days after the last treatment session.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Single arm trial with the Enhanced Lithotripsy System
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Feasibility Study of an Enhanced Lithotripsy System in the Treatment of Urinary Stone Disease
Actual Study Start Date : July 22, 2017
Actual Primary Completion Date : June 25, 2018
Actual Study Completion Date : June 25, 2018

Arm Intervention/treatment
Experimental: Enhanced Lithotripsy System
Treatment for urinary stones with the Enhanced Lithotripsy System
Device: Enhanced Lithotripsy System
The Enhanced Lithotripsy System is a type of lithotripsy system comprising a console, treatment head, and Acoustic Energy Focusing material. Operation of the Enhanced Lithotripsy System entails combined action of extracorporeal insonation and Acoustic Energy Focusing material to fragment urinary stones.




Primary Outcome Measures :
  1. Proportion of subjects with serious device-related adverse events (safety) [ Time Frame: 30 days after last treatment session ]
    Safety: Proportion of subjects with serious device-related adverse events


Secondary Outcome Measures :
  1. Successful treatment of urinary stone [ Time Frame: 14 days after last treatment session ]
    Proportion of subjects with successful treatment or urinary stone


Other Outcome Measures:
  1. Pain [ Time Frame: Baseline and Days 1, 2, 3, 7, 14, and 30 ]
    Change in pain score

  2. Pain medication usage [ Time Frame: Baseline and Days 1, 2, 3, 7, 14, and 30 ]
    Use and quantity of pain medication

  3. Time to passage of stones [ Time Frame: 30 days after last treatment session ]
    Post-Treatment time to passage of stone fragments after treatment



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:

  • Individuals presenting with one urinary stone—apparent on a computed tomography scan within the last 14 days
  • Males and females aged 18 or older
  • Capable of giving informed consent, and willing to have the informed consent process videotaped
  • Stone size, as estimated by pre-operative computed tomography, with all dimensions 15 mm or less.

Exclusion Criteria:

  • Individuals under 18 years of age
  • Individuals with radiolucent stones
  • Individuals with stones in the lower pole of kidney
  • Individuals not following up in the treating hospital
  • Individuals with history of cystinuria
  • Individuals with urine pH below 5.5
  • Individuals with untreated urinary tract infection
  • Individuals who are not willing to use adequate method of contraception during the study period
  • Women who are pregnant, lactating or planning pregnancy during the study period
  • Individuals with a coagulation abnormality or taking prescription anticoagulants.
  • Individuals with mobility issues who are unable to comfortably lie still for up to 30 minutes or roll from their back to their side
  • Individuals belonging to a vulnerable group (pregnant, mentally disabled, physically disabled, prisoner, etc.)
  • Individuals with a body mass index greater than 35
  • Individuals with ASA score of 3 or greater general anesthesia risk level
  • Known sensitivity to possible medications used before, during, or after the treatment procedure, including but not limited to the following: sedative agents, general anesthetics, topical anesthetics, and opioid analgesics

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): NCT03195920


Locations
Layout table for location information
India
Muljibhai Patel Urological Hospital
Nadiad, Gujarat, India, 387 001
Sponsors and Collaborators
Applaud Medical, Inc.
Investigators
Layout table for investigator information
Principal Investigator: Mahesh Desai, MS, FRCS Muljibhai Patel Urological Hospital

Layout table for additonal information
Responsible Party: Applaud Medical, Inc.
ClinicalTrials.gov Identifier: NCT03195920     History of Changes
Other Study ID Numbers: 2017-02
First Posted: June 22, 2017    Key Record Dates
Last Update Posted: June 27, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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: Yes
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
Layout table for MeSH terms
Urinary Calculi
Urolithiasis
Calculi
Pathological Conditions, Anatomical
Urologic Diseases