NCT07559214

Brief Summary

To compare between FANS \& DISS in :

  • Operative time
  • Stone free rate
  • Complications
  • Amount of fluid irrigation

Trial Health

65
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
15mo left

Started Jun 2026

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 10, 2026

Completed
20 days until next milestone

First Posted

Study publicly available on registry

April 30, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

June 1, 2026

Expected
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2027

3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2027

Last Updated

April 30, 2026

Status Verified

April 1, 2026

Enrollment Period

1 year

First QC Date

April 10, 2026

Last Update Submit

April 23, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Operative time

    The operative time is the duration of surgical procedure

    <60 minutes

Study Arms (2)

Flexible and navigable access sheath (FANS)

EXPERIMENTAL

In patients undergoing the FANS procedure , an access sheath with a bendable tip and aspiration feature will be placed into the relevant ureter up to the renal pelvis over the guidewire. The single-use flexible scope will be passed through the access sheath, and the renal collecting system. After this maneuver, the tip of the placed access sheath will be pushed into the renal calyces or pelvis under the guidance of the flexible URS and a holmium fiber will be used to pulverize the stones with a 273-µm fiber. In this group, stones were disintegrated (fragmented) into an adequate size (\< 3 mm) to allow an efficient extraction with the help of active aspiration, finished by insertion of JJ in all patients.

Procedure: Flexible ureteroscopy

Direct in scope suction (DISS)

EXPERIMENTAL

In the DISS group, a single-use flexible URS with a direct in-scope suction system will be introduced over the placed guidewire and navigated into the renal pelvis without the use of an access sheath. The suctioning port on the ureteroscope and the laser fiber operates via the same port. In this group, the dusting preset of the same laser device will be used to disintegrate the stones. While continuous irrigation was applied to ensure optimum visualization, finished by insertion of JJ in all patients

Procedure: Flexible ureteroscopy

Interventions

Unlike traditional rigid sheaths, FANS features a deflectable tip that can be guided into specific calyces, allowing for synchronized suction and active fragment evacuation. Conversely, Direct In-Scope Suction (DISS) utilizes a sheathless approach, where suction is integrated directly into the ureteroscope. While DISS avoids potential ureteral trauma associated with access sheaths, FANS is often associated with shorter operative times due to its superior irrigation-aspiration efficiency

Also known as: FURS
Direct in scope suction (DISS)Flexible and navigable access sheath (FANS)

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • All patients \< 18 years old presented with renal stone \> 2cm whatever the site of the stone (pelvic or calyceal)

You may not qualify if:

  • Inaccessibility to introduce access sheath or FURS
  • Previous Inserted JJ stent
  • Active UTI
  • Patients refuse to participate in the protocol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Kidney Calculi

Condition Hierarchy (Ancestors)

NephrolithiasisKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrolithiasisUrinary CalculiMale Urogenital DiseasesCalculiPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
resident physician

Study Record Dates

First Submitted

April 10, 2026

First Posted

April 30, 2026

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

September 1, 2027

Last Updated

April 30, 2026

Record last verified: 2026-04