NCT02751281

Brief Summary

The purpose of this study is to determine which type of percutaneous nephrolithotomy is better in large kidney stones

Trial Health

100
On Track

Trial Health Score

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

Enrollment
180

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Dec 2014

Shorter than P25 for phase_2

Status
completed

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

December 1, 2014

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

April 18, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 26, 2016

Completed
Last Updated

April 26, 2016

Status Verified

April 1, 2016

Enrollment Period

1.3 years

First QC Date

April 18, 2016

Last Update Submit

April 21, 2016

Conditions

Kidney Stone

Keywords

pneumaticultra-sonicpercutaneous nephrolithotomy

Outcome Measures

Primary Outcomes (1)

  • stone free rate

    3 months after surgery

Secondary Outcomes (1)

  • hemoglobin loss

    2 days after surgery

Study Arms (2)

pneumatic percutaneous nephrolithotomy

ACTIVE COMPARATOR

pneumatic percutaneous nephrolithotomy is type of surgery in treatment of kidney stone

Procedure: Pneumatic percutaneous nephrolithotomy

Ultra-sonic percutaneous nephrolithotomy

ACTIVE COMPARATOR

Ultra-sonic percutaneous nephrolithotomy is type of surgery in treatment of kidney stone

Procedure: Ultra-sonic percutaneous nephrolithotomy

Interventions

Pneumatic percutaneous nephrolithotomyPROCEDURE

Pneumatic percutaneous nephrolithotomy is type of surgery that we use pneumatic lithotripter to treat kidney stone

pneumatic percutaneous nephrolithotomy
Ultra-sonic percutaneous nephrolithotomyPROCEDURE

Ultra-sonic percutaneous nephrolithotomy is type of surgery that we use ultra-sonic lithotripter to treat kidney stone

Ultra-sonic percutaneous nephrolithotomy

Eligibility Criteria

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

You may qualify if:

  • \- patients with \>2cm kidney stone

You may not qualify if:

  • Pregnant women
  • patients with coagulopathies
  • patients with scattered stones who needed several accesses

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 Officials

  • Nasser Simforoosh, Prof

    Shahid Beheshty University of Medical Sciences

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

April 18, 2016

First Posted

April 26, 2016

Study Start

December 1, 2014

Primary Completion

April 1, 2016

Study Completion

April 1, 2016

Last Updated

April 26, 2016

Record last verified: 2016-04