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A Comparative Study Between the Usage of Flexible and Navigable Suction Ureteral Access Sheath Versus Traditional Access Sheath in Retrograde Intrarenal Surgeries

ConditionsStones, KidneyUreter Stones
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age14+
SponsorYosseif elhousseiny ammar ahmed

About this trial

A comparative study between the Usage of Flexible and Navigable Suction Ureteral Access Sheath (FANS) versus Traditional Access sheath in RIRS : Randomized controlled trial .

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥14 years old in patients not known to have stone forming medical conditions.

Renal stones diameter of ≤2 cm confirmed by CT with all types of configurations (branching & non-branching).

Non - recurrent cases with no history of previous open renal surgeries or PCNL with normal renal anatomy.

Patients with non - infected urine analysis.

Disqualifiers

Patients with abnormal urinary tract anatomy (such as horseshoe kidney or ileal conduit).

Patients with medical conditions promoting stone formation (hyperparathyroidism - gout).

Patients with history of stones on the same side with previous open surgical intervention or PCNL .

Patients with e-GFR < 60 ml / min.

Trial design

Design model

Parallel

Treatments tested in this trial

  • FURS

    Procedure/Surgery

    FURS using traditional UAS \& FANS

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: Using FANSActive comparator 1 intervention
Group B: Using traditional UASActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

• Stone-free rate (SFR).

Time frame
12 weeks postoperatively

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Yosseif elhousseiny ammar ahmed

Lead sponsor

Cairo University

Sponsor institution

Source ClinicalTrials.gov
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