NCT06786715

Brief Summary

Suction has been initially used in endoscopic stone management for more than 25 years during PCNL, but the emergence of new devices applying suction through patented ureteroscopes, ureteral access sheaths (UAS) and ureteral catheters led to application of suction in URS/RIRS. The application of ureteral access sheath (UAS) in RIRS can improve surgical vision , reduce intrarenal pressure (IRP) ,and decrease postoperative infectious complications .

Trial Health

75
On Track

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
1mo left

Started Jan 2025

Geographic Reach
1 country

1 active site

Status
active not 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

Study Progress95%
Jan 2025Jun 2026

Study Start

First participant enrolled

January 1, 2025

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

January 10, 2025

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 22, 2025

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Expected
Last Updated

January 22, 2025

Status Verified

January 1, 2025

Enrollment Period

12 months

First QC Date

January 10, 2025

Last Update Submit

January 15, 2025

Conditions

Renal Stone

Outcome Measures

Primary Outcomes (1)

  • Stone free rate

    No residual or non siginficant residual less than 4 mm

    One month

Secondary Outcomes (2)

  • Operatove data

    2 hours

  • Post operative complication

    2 days

Study Arms (2)

Retrograde intrarenal surgery using DISS

ACTIVE COMPARATOR

Retrograde intrarenal surgery using DISS

Device: Retrograde intrarenal surgery using DISS

Retrograde intrarenal surgery using FANS

ACTIVE COMPARATOR

Retrograde intrarenal surgery using FANS

Device: Retrograde intrarenal surgery using FANS

Interventions

Retrograde intrarenal surgery using DISSDEVICE

Retrograde intrarenal surgery using Direct in scope suction for renal stone up to 3 cm

Retrograde intrarenal surgery using DISS
Retrograde intrarenal surgery using FANSDEVICE

Retrograde intrarenal surgery using Flexible and navigable suction for renal stone up to 3 cm

Retrograde intrarenal surgery using FANS

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Single stone
  • Medium sized stone ≤ 3 cm
  • Renal stone
  • age group \> 18

You may not qualify if:

  • multiple renal stones
  • stone size \> 3 cm
  • age group \< 18
  • solitary kidney
  • Obstruction distal to the stone.
  • urinary tract infection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Elsayed Abdelhalim

Zagazig, 44749, Egypt

Location

MeSH Terms

Conditions

Nephrolithiasis

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrolithiasisMale Urogenital Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
research randomizer
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant lecturer of urology

Study Record Dates

First Submitted

January 10, 2025

First Posted

January 22, 2025

Study Start

January 1, 2025

Primary Completion

December 31, 2025

Study Completion (Estimated)

June 1, 2026

Last Updated

January 22, 2025

Record last verified: 2025-01

Locations

EG(1)