Impact of Forced Diuresis on the Residual Fragment Rate After Flexible Ureteroscopy for Destruction of Kidney Stones With Laser
Recruiting
Phase 3Interventional Study
Kidney Stone
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 – 80
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
374 (estimated)
Sponsor
University Hospital, Tours · Other
Who this trial is looking for
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In view of the positive results of the numerous studies conducted on forced diuresis after extra-corporeal lithotripsy, the investigators chose to evaluate forced diuresis by injection of Furosemide associated with intravenous hydration, which has never before been the subject of a specific analysis.
Trial Locations
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State
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Eligibility Criteria
Inclusion Criteria:
* Patients ≥ 18 years old and \< 80 years old
* With the need to perform a flexible ureteroscopy with destruction of the kidney stones with laser
* Participants covered by or entitled to social security
* Written informed consent obtained from the participant
* Ability for parti…
Inclusion Criteria:
* Patients ≥ 18 years old and \< 80 years old
* With the need to perform a flexible ureteroscopy with destruction of the kidney stones with laser
* Participants covered by or entitled to social security
* Written informed consent obtained from the participant
* Ability for participant to comply with the requirements of the study
Exclusion Criteria:
* Persons covered by articles L1121-5 to L1121-8 of the CSP (corresponding to all protected persons: pregnant women, parturients, nursing mothers, persons deprived of their liberty by judicial or administrative decision, minors, and persons subject to a legal protection measure: guardianship or trusteeship)
* Contra-indication to Furosemide:
* Hyper-sensitivity to the active substance or one of the excipients
* Hyper-sensitivity to Sulfonamide
* Renal failure with oligo-anuria refractory to Furosemide
* Hypokalemia \< 3,5 mmol/L
* Severe hyponatremia
* Hypovolemia with or without hypotension or dehydration
* Ongoing hepatitis, hepatic insufficiency severe and hepatic encephalopathy
* Patient having Furosemide as usual treatment
* Patient requiring an injection of Aminoside or Vancomycin before or during the procedure
* Participation in other interventional research with an investigational drug or medical device
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