Clinical Trial Evaluating the Efficiency of Holmium Laser Settings on Urinary Stones
24. august 2021 opdateret af: University of Wisconsin, Madison
The primary objective of this study is to compare the time to acceptable stone fragmentation during clinical use of the holmium laser when using energy settings 0.2J vs 0.8J.
The hypothesis is that holmium laser energy settings 0.8J will require less time than lower energy settings 0.2J for fragmenting urinary stones.
The clinical practice is to treat urinary stones until the stone is reduced to fragments ≤ 2 mm in size.
This is determined by using the laser fiber which is 273 microns to visually estimate the size of the resultant fragments as described by Patel et al, J Endo 2014.
Investigators will standardize the effect of stone size by creating a ratio of stone size to treatment time.
In this study, the frequency is set at 15Hz.
Thus, the study contains two arms: 0.2J&15Hz, and 0.8J&15Hz.
Patients will be randomized into the two groups by the ratio of 1:1.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
The only interventions imposed on subjects as a result of this study are (1) pre-procedural randomization to laser lithotripsy with either 0.2J or 0.8J energy setting, and (2) the use of patient information in describing results. All the other activities are part of the routine clinical practice in the department. Participation in the study will not alter the patients' preoperative, or postoperative care. During surgery, patients' stones will be treated in accordance with the routine clinical practice of fragmenting stones into small pieces (<2 mm). All patients enrolled will undergo routine post-operative follow up including clinic appointments and imaging evaluation. Any complications will be recorded, reported, and treated appropriately. A fixed frequency will be used (15Hz). Thus, the study contains two arms: 0.2J&15Hz, and 0.8J&15Hz. Patients will be randomized into the two groups by the ratio of 1:1. A total of 1 clinic visit (i.e., the stone surgery, approximately 5-6 hours, depending on the duration of the surgery) is needed for this study.
The study procedures are:
- A study team member who is affiliated with the patient's clinical care (e.g., the surgeon) will initially approach the patients who are scheduled laser lithotripsy treatment of urinary stones. (i.e. informed that there's a research study they may be eligible for, and asked if they want to learn more about it).
- If the patient is interested in the study, a member of the research team will approach him/her for enrollment.
- Once the consent form is obtained, patients' medical background will be reviewed for inclusion/exclusion criteria. Patients who meet the inclusion criteria will be included in the study; patients who do not meet the inclusion criteria will be excluded.
- Patients will be randomized to either 0.2J&15Hz or 0.8J&15Hz (randomization ratio 1:1) group.
- Patients will undergo stone surgeries with the laser setting that they are randomized to. The patient's stone(s) will be treated in accordance with the routine clinical practice of fragmenting stone into small pieces (≤ 2mm). The faculty surgeon (i.e., Dr. Nakada) will perform all surgeries.
- Fragmentation time as well as other information (total surgery time, complications, stone information, and number of stones treated) is collected.
- After surgery, the patients will then continue on normal postoperative pathway. Postoperative complications will be collected.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
40
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Wisconsin
-
Madison, Wisconsin, Forenede Stater, 53792
- University of Wisconsin
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Patients at least 18 years of age
- Patients with urinary stones who require endoscopic treatment
Exclusion Criteria:
- Patients < 18 years of age
- Pregnant patients
- Pre-menopausal females who have not been on approved birth control for at least 1 month pre-operatively
- Patients with stones known to be refractory to treatment with the holmium laser
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Firedobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: Holmium:YAG laser: 0.2J&15Hz
Patients are assigned to treat stones with 0.2J&15Hz of the holmium laser.
|
Treatment of urolithiasis is commonly done using the holmium:YAG laser as this has been shown to be a safe and effective method of treating a wide variety of stones and is currently considered the standard of care (AUA Guideline Panel on the Surgical Management of Stones)
|
|
Eksperimentel: Holmium:YAG laser: 0.8J&15Hz
Patients are assigned to treat stones with 0.8J&15Hz of the holmium laser.
|
Treatment of urolithiasis is commonly done using the holmium:YAG laser as this has been shown to be a safe and effective method of treating a wide variety of stones and is currently considered the standard of care (AUA Guideline Panel on the Surgical Management of Stones)
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Fragmentation Time
Tidsramme: up to 6 hours
|
The time to fragment a stone into small pieces (≤2 mm, which is our current institutional practice)
|
up to 6 hours
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Total Operative Time
Tidsramme: up to 6 hours
|
up to 6 hours
|
|
|
Pre-Operative Stone Size
Tidsramme: Retrospective review of health chart at Baseline
|
Pre-operative stone size (on pre-operative CT) will be reported in millimeters.
|
Retrospective review of health chart at Baseline
|
|
Number of Participants With Either Ureteral or Renal Location of Urinary Stone
Tidsramme: up to 6 hours
|
Urinary stone location will be classified as renal or ureter.
|
up to 6 hours
|
|
Number of Participants Treated for Either Single or Multiple Urinary Stones
Tidsramme: up to 6 hours
|
up to 6 hours
|
|
|
Density of Urinary Stones
Tidsramme: up to 6 hours
|
up to 6 hours
|
|
|
Number of Participants With Urinary Stone Fragment Size of 1, 2 or 3 mm
Tidsramme: up to 6 hours
|
Size of fragments created will be assessed using the laser fiber size as a comparison.
|
up to 6 hours
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Datoer for undersøgelser
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Studer store datoer
Studiestart (Faktiske)
30. juli 2019
Primær færdiggørelse (Faktiske)
24. marts 2021
Studieafslutning (Faktiske)
24. marts 2021
Datoer for studieregistrering
Først indsendt
14. november 2017
Først indsendt, der opfyldte QC-kriterier
3. maj 2018
Først opslået (Faktiske)
16. maj 2018
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
20. september 2021
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
24. august 2021
Sidst verificeret
1. august 2020
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2017-0252
- A539800 (Anden identifikator: UW Madison)
- SMPH/UROLOGY (Anden identifikator: UW Madison)
- Protocol Version 10/30/2017 (Anden identifikator: UW Madison)
Plan for individuelle deltagerdata (IPD)
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