NCT04578795

Brief Summary

To study the Effectiveness of single use flexible Ureteroscopes in treatment of renal stones

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2020

Geographic Reach
1 country

1 active site

Status
unknown

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 Start

First participant enrolled

September 1, 2020

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

September 28, 2020

Completed
10 days until next milestone

First Posted

Study publicly available on registry

October 8, 2020

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2021

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2021

Completed
Last Updated

October 8, 2020

Status Verified

October 1, 2020

Enrollment Period

7 months

First QC Date

September 28, 2020

Last Update Submit

October 1, 2020

Conditions

Renal Stones

Keywords

Single use flexible ureteroscopy- renal stones

Outcome Measures

Primary Outcomes (1)

  • Clearance of renal stones

    the effectiveness of single use flexible ureteroscopy in treatment of renal stones in eradicate renal stones

    One month after operation

Secondary Outcomes (1)

  • Post operative complications after flexible ureteroscopy

    3 months after operation

Study Arms (1)

Pt underwent single use flexible ureteroscopy

EXPERIMENTAL

Patients with renal stones who will operated by single use flexible ureteroscopy

Device: Single use flexible ureteroscopy (PUSEN-OLIMPUS)

Interventions

Single use flexible ureteroscopy (PUSEN-OLIMPUS)DEVICE

single use flexible ureteroscopy

Pt underwent single use flexible ureteroscopy

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • \- All cases indicated for flexible in our department (stone kidney up to 2 cm - failed ESWL, difficult PCNL

You may not qualify if:

  • Staghorn stones

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hossam abdelruhman kandeel

Shibīn al Kawm, 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
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Urology resident menoufia Faculty of Medicine

Study Record Dates

First Submitted

September 28, 2020

First Posted

October 8, 2020

Study Start

September 1, 2020

Primary Completion

April 1, 2021

Study Completion

July 30, 2021

Last Updated

October 8, 2020

Record last verified: 2020-10

Locations

EG(1)