NCT04610840

Brief Summary

  • A single-center randomized study to evaluate the safety and effectiveness of direct puncture of the caliceal system in mini-percutaneous nephrolithotripsy.
  • 60 patients
  • Inclusion criteria:
  • all patients aged 18 to 70 years who are planning mini-PCNL, ready to consent to the study
  • ASA scale 1-3
  • Solitary stone up to 2.5 cm
  • Single access to the caliceal system
  • Exclusion criteria:
  • Active infectious process
  • Coagulopathies
  • Abnormalities of the urinary system

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
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 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

July 1, 2020

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 5, 2020

Completed
3 months until next milestone

First Posted

Study publicly available on registry

November 2, 2020

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2022

Completed
Last Updated

November 9, 2021

Status Verified

November 1, 2021

Enrollment Period

1.6 years

First QC Date

August 5, 2020

Last Update Submit

November 8, 2021

Conditions

Urolithiasis

Keywords

urolithiasisPCNLdirect puncture

Outcome Measures

Primary Outcomes (4)

  • Puncture duration

    Measurement of puncture duration (in seconds)

    during the operation (mini-PCNL)

  • Number of patients with successful direct puncture

    Evaluation of efficacy

    during the operation (mini-PCNL)

  • Purity of a visual intraoperative field

    Excellent, Moderate, Poor visualization

    during the operation (mini-PCNL)

  • Body pain

    Using the Visual Analogue Pain Scale (VAS), pain assessment is planned at 2 hours, 6 hours, 12 hours and 24 hours after surgery

    24 hours after operation

Study Arms (2)

Direct puncture

ACTIVE COMPARATOR

Direct puncture of the caliceal system performed under ultrasound or Xray control

Procedure: Puncture of the caliceal system

Non-direct puncture

ACTIVE COMPARATOR

Puncture of the caliceal system performed under ultrasound or Xray control and retrograde contrast

Procedure: Puncture of the caliceal system

Interventions

Puncture of the caliceal systemPROCEDURE

Puncture of the caliceal system under ultrasound/Xray control

Direct punctureNon-direct puncture

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients aged 18 to 70 years who are scheduled for mini-PCNL, ready to consent to the study
  • ASA scale 1-3
  • Solitary kidney stone up to 2.5 cm
  • One access to the caliceal system

You may not qualify if:

  • Active infectious process
  • Coagulopathies
  • Abnormalities of the urinary system

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

First Pavlov Saint Petersburg University

Saint Petersburg, 197342, Russia

RECRUITING

MeSH Terms

Conditions

Urolithiasis

Condition Hierarchy (Ancestors)

Urologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Central Study Contacts

Dmitry S Gorelov

CONTACT

+79217964892dsgorelov@mail.ru

Vladimir M Obidniak

CONTACT

+79218944746v.obidniak@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 5, 2020

First Posted

November 2, 2020

Study Start

July 1, 2020

Primary Completion

February 1, 2022

Study Completion

April 1, 2022

Last Updated

November 9, 2021

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will not share

Locations

RU(1)