NCT02943772

Brief Summary

The investigators propose to examine the effect of local cooling of testis in participants with acute epididymitis or orchiepididymitis on participants reported pain level and analgetics consumption.

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 pain

Timeline
Completed

Started Sep 2016

Longer than P75 for not_applicable pain

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, 2016

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

September 26, 2016

Completed
29 days until next milestone

First Posted

Study publicly available on registry

October 25, 2016

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 7, 2019

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2020

Completed
Last Updated

August 16, 2019

Status Verified

August 1, 2019

Enrollment Period

3.2 years

First QC Date

September 26, 2016

Last Update Submit

August 15, 2019

Conditions

Pain

Outcome Measures

Primary Outcomes (1)

  • change in pain level

    intervention and measurement will be examined three times a day following brick/cooled brick

    pain level change from baseline three times a day following the intervention of brick/cooled brick from randomization throughout the hospitalization for at least 24 hours of hospitalization and up to 50weeks

Secondary Outcomes (1)

  • Total consumption in grams of protocol analgetics

    analgetics consumption will be recorded from randomization throughout the hospitalization for at least 24 hours of hospitalization and up to 50weeks

Study Arms (2)

Local hypothermia

EXPERIMENTAL

Local application of a brick cooled to -20(celsius)

Other: Local hypothermia

Control

SHAM COMPARATOR

Local application of a brick in room temperature

Other: Control

Interventions

Local hypothermiaOTHER

Cooled brick

Local hypothermia
ControlOTHER

Control brick

Control

Eligibility Criteria

Age18 Years - 99 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male patients 18-99 years
  • Acute epididymitis or acute orchiepididymitis

You may not qualify if:

  • Patient unable to informed consent
  • Suspicion of testicular malignancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kaplan Medical Center

Rehovot, Israel

RECRUITING

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Dan Leibovici, MD

    Kapaln medical center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Igal Shpunt, MD

CONTACT

+972-8-944-1642igal2k@gmail.com

Yuval Avda, MD

CONTACT

+972-8-944-1516yuvalab@clalit.org.il

Study Design

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

Study Record Dates

First Submitted

September 26, 2016

First Posted

October 25, 2016

Study Start

September 1, 2016

Primary Completion

November 7, 2019

Study Completion

November 1, 2020

Last Updated

August 16, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share

Locations

IL(1)