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NCT04519294 · ClinicalTrials.gov registry record · NA

Comparison of Laser Lithotripsy With and Without Steerable Ureteroscopic Renal Evacuation (SURE)

A NA study, sponsored by Calyxo.

Completed
Registry status
NA
Development phase
132
Enrollment target

NCT04519294: Completed NA study, sponsored by Calyxo.

NCT04519294 is a NA study that has completed, run by Calyxo. The registered enrollment target is 132 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (91% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04519294, a NA study, has completed, sponsored by Calyxo.

COMPLETED
Registry status
NA
Development phase
132 participants
Enrollment target

Study Summary

The purpose of the study is to compare the effects, good and/or bad, of a treatment for removing kidney stones called the SURE procedure for stone evacuation to the standard treatment using a basket for stone removal.

Primary Outcome

The primary efficacy endpoint is the SFR, where stone free status is defined as zero residual fragments at 30 days observed on non-contrast CT (NCCT) (1.25mm slice thickness) by blinded central reviewer(s). The SFR is calculated by determining the number of subjects in each treatment arm with a stone free status of zero fragments and dividing that by the total number of subjects treated in the respective treatment arm.

Interventions

  • DEVICE SURE
  • DEVICE Standard Ureteroscopy (Basketing)

Trial Details

FieldValue
Enrollment Target 132 participants
Start Date 2021-06-16
Est. Completion 2025-04-30
Phase NA
Calyxo

3 total trials

What the finished NCT04519294 record still lists

NCT04519294 is an interventional study that assigns participants to a tested intervention. The registered 132 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (91% lower).

The record links to 0 conditions, and to 2 interventions - of which SURE is the first listed.

NCT04519294 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04519294 about?

NCT04519294 is a clinical study titled "Comparison of Laser Lithotripsy With and Without Steerable Ureteroscopic Renal Evacuation (SURE)". The purpose of the study is to compare the effects, good and/or bad, of a treatment for removing kidney stones called the SURE procedure for stone evacuation to the standard treatment using a basket for stone removal.

What is the current status of trial NCT04519294?

This trial is currently completed. It is a NA study. The enrollment target is 132 participants. The study started on 2021-06-16. Estimated completion is 2025-04-30.

What interventions are being tested in trial NCT04519294?

The interventions under investigation include: SURE (DEVICE), Standard Ureteroscopy (Basketing) (DEVICE).

Who is sponsoring clinical trial NCT04519294?

This trial is sponsored by Calyxo, which has 3 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT04519294's enrollment target sits among peer trials

132 729th of 2000 higher than 1,269 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT04519294, the US trial registry maintained by the National Library of Medicine. NCT04519294 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.