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High Powered Stone Dusting vs. Fragmentation and Basketing at Time of Ureteroscopy

Primary Purpose

Kidney Stone, Ureteral Stone

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Dusting
Basket extraction
Sponsored by
Northwestern University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Kidney Stone

Eligibility Criteria

18 Years - 89 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • >18 years of age
  • undergoing ureteroscopic stone extraction
  • Stone size 6mm stones or greater and the location to mid ureter or higher
  • Willing to sign informed consent form
  • Able to read, understand, and complete patient questionnaires, and pain questionnaires

Exclusion Criteria:

  • < 18 years of age
  • Inability to provide informed consent
  • Concomitant surgery (i.e. Percutaneous nephrolithotomy, Holmium laser enucleation of the prostate
  • Solitary kidney
  • Nephrocalcinosis
  • Members of vulnerable patient populations
  • Patients without access to a phone that can receive txt messages

Sites / Locations

  • Northwestern Memorial HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

laser dusting

basketing

Arm Description

In the "dusting" arm, the ureteroscope will be advanced into the kidney or ureter over an access wire without an access sheath in place. The identified stone will be dusted using a 200 micron Moses laser fiber at a setting of 0.3-0.6 J and 50-120 Hz using the Moses 2.0 laser system. Stone dusting will continue until the surgeon feels the fragments are all negligible in size and would be able to pass. One small piece will be extracted for analysis and the remainder will be left to pass spontaneously. If there is no evidence of injury or swelling of the ureter at the conclusion of the case a stent will be omitted.

In the Basketing arm, a ureteral access sheath (UAS) will be placed per standard fashion. The ureteroscope will be introduced into the kidney and the stone fragmented at a setting of 0.8-1.0 J and 6-15 Hz. The resultant fragments will be basket extracted through the sheath for analysis. All fragments will be removed until no residual stone remains. At the time of UAS removal the ureter will be inspected. If there is no evidence of ureteral injury or swelling then a stent will be omitted.

Outcomes

Primary Outcome Measures

Stone free rate: clinical
patients with no clinical evidence of kidney stones on the treated side
Stone free rate: imaging
patients with no radiographic evidence of kidney stones on the treated side

Secondary Outcome Measures

Patient quality of life- pain intensity
patient quality of life measures as assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS) questionnaire Pain Intensity - Short Form 3a. Higher score indicates higher pain levels. Lowest score 3, highest score 15.
Patient quality of life- pain interference
patient quality of life measures as assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS) questionnaire Pain Interference - Short Form 6b. Higher scores indicate higher levels of pain interference. Lowest score is 6, highest score is 30.
Return to work
Days missed from work after surgery
Daily activity level
Days until patients have returned to baseline pre-surgery daily activity level

Full Information

First Posted
August 6, 2021
Last Updated
September 11, 2023
Sponsor
Northwestern University
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1. Study Identification

Unique Protocol Identification Number
NCT05006937
Brief Title
High Powered Stone Dusting vs. Fragmentation and Basketing at Time of Ureteroscopy
Official Title
Prospective, Randomized Study to Assess Patient Satisfaction and Stone Free Effect of High Powered Stone Dusting vs. Fragmentation and Basketing at Time of Ureteroscopy
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 28, 2021 (Actual)
Primary Completion Date
July 1, 2023 (Actual)
Study Completion Date
December 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwestern University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to determine the differences in stone free results, patient side effects, and patient satisfaction between dusting vs. basket extraction for kidney and ureteral stones (a kidney stone located in the tube between the kidney and bladder) 6 mm and greater in size undergoing ureteroscopic treatment. Dusting is when a laser is used to break a stone down into tiny fragments that are able to pass through the urine. Basket extraction is when a small wire basket is used to remove stone fragments.
Detailed Description
On the day of surgery, the treatment assigned to the patient will be determined by chance, like flipping a coin. Neither the patient nor the study doctor will choose the treatment type. Each patient will have an equal chance of being given either surgical treatment. One group will have stones treated with high-powered laser dusting and the dust produced will pass spontaneously through the urine. The other group will have stones treated with low power laser fragmentation and stones will be removed using a basket. The surgical procedure will not differ from the treatment a patient would receive if he/she were not in this study. After surgery, participants will complete a pain assessment questionnaire in the outpatient recovery area before being discharged to go home. Participants will also receive a daily email or text message to assess pain and daily activities. Participants will answer these questions daily until pain has resolved and daily activities have returned to baseline levels. Six weeks after surgery, participants will undergo an ultrasound to assess for swelling of a kidney due to a build-up of urine (called hydronephrosis), which is standard of practice after ureteroscopy. Participants will also return to the urology clinic 12 weeks after surgery for a standard of care follow up visit. At this visit, participants will undergo standard of care procedures known as renal bladder ultrasound and kidney ureter bladder abdominal x-ray to evaluate for stones. Participants will also complete another pain assessment questionnaire at this appointment. Researchers will review the medical record to evaluate the effectiveness of the surgery at removing kidney stones and preventing kidney stone recurrence as well as to track quality of life outcomes.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Stone, Ureteral Stone

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
168 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
laser dusting
Arm Type
Active Comparator
Arm Description
In the "dusting" arm, the ureteroscope will be advanced into the kidney or ureter over an access wire without an access sheath in place. The identified stone will be dusted using a 200 micron Moses laser fiber at a setting of 0.3-0.6 J and 50-120 Hz using the Moses 2.0 laser system. Stone dusting will continue until the surgeon feels the fragments are all negligible in size and would be able to pass. One small piece will be extracted for analysis and the remainder will be left to pass spontaneously. If there is no evidence of injury or swelling of the ureter at the conclusion of the case a stent will be omitted.
Arm Title
basketing
Arm Type
Active Comparator
Arm Description
In the Basketing arm, a ureteral access sheath (UAS) will be placed per standard fashion. The ureteroscope will be introduced into the kidney and the stone fragmented at a setting of 0.8-1.0 J and 6-15 Hz. The resultant fragments will be basket extracted through the sheath for analysis. All fragments will be removed until no residual stone remains. At the time of UAS removal the ureter will be inspected. If there is no evidence of ureteral injury or swelling then a stent will be omitted.
Intervention Type
Procedure
Intervention Name(s)
Dusting
Intervention Description
Dusting is when a laser is used to break a stone down into tiny fragments that are able to pass through the urine.
Intervention Type
Procedure
Intervention Name(s)
Basket extraction
Intervention Description
Basket extraction is when a small wire basket is used to remove stone fragments.
Primary Outcome Measure Information:
Title
Stone free rate: clinical
Description
patients with no clinical evidence of kidney stones on the treated side
Time Frame
6 weeks
Title
Stone free rate: imaging
Description
patients with no radiographic evidence of kidney stones on the treated side
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Patient quality of life- pain intensity
Description
patient quality of life measures as assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS) questionnaire Pain Intensity - Short Form 3a. Higher score indicates higher pain levels. Lowest score 3, highest score 15.
Time Frame
12 weeks
Title
Patient quality of life- pain interference
Description
patient quality of life measures as assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS) questionnaire Pain Interference - Short Form 6b. Higher scores indicate higher levels of pain interference. Lowest score is 6, highest score is 30.
Time Frame
12 weeks
Title
Return to work
Description
Days missed from work after surgery
Time Frame
12 weeks
Title
Daily activity level
Description
Days until patients have returned to baseline pre-surgery daily activity level
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: >18 years of age undergoing ureteroscopic stone extraction Stone size 6mm stones or greater and the location to mid ureter or higher Willing to sign informed consent form Able to read, understand, and complete patient questionnaires, and pain questionnaires Exclusion Criteria: < 18 years of age Inability to provide informed consent Concomitant surgery (i.e. Percutaneous nephrolithotomy, Holmium laser enucleation of the prostate Solitary kidney Nephrocalcinosis Members of vulnerable patient populations Patients without access to a phone that can receive txt messages
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Matthew Lee, MD
Phone
3126958146
Email
matthew.lee@nm.org
First Name & Middle Initial & Last Name or Official Title & Degree
Mark Assmus, MD
Phone
3126958146
Email
mark.assmus@nm.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amy Krambeck, MD
Organizational Affiliation
Northwestern University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northwestern Memorial Hospital
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mary Kate Keeter, MPH
First Name & Middle Initial & Last Name & Degree
Amy Krambeck, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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High Powered Stone Dusting vs. Fragmentation and Basketing at Time of Ureteroscopy

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