NCT05916963 Impact of Forced Diuresis on the Residual Fragment Rate After Flexible Ureteroscopy for Destruction of Kidney Stones With Laser
| NCT ID | NCT05916963 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | University Hospital, Tours |
| Condition | Kidney Stone |
| Study Type | INTERVENTIONAL |
| Enrollment | 374 participants |
| Start Date | 2024-01-04 |
| Primary Completion | 2026-04-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 374 participants in total. It began in 2024-01-04 with a primary completion date of 2026-04-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05916963 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Kidney Stone. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05916963 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 374 participants.
Is NCT05916963 currently recruiting?
Yes, NCT05916963 is actively recruiting participants. Contact the research team at marielou.letouche@gmail.com for enrollment information.
Where is the NCT05916963 trial being conducted?
This trial is being conducted at Angers, France, Lyon, France, Nice, France, Nîmes, France and 5 additional locations.
Who is sponsoring the NCT05916963 clinical trial?
NCT05916963 is sponsored by University Hospital, Tours. The trial plans to enroll 374 participants.
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