NCT03171974

Brief Summary

Ultrasound guided treatment of steroids for capsular contracture in patients with reconstructed/augmented breast

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
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2017

Typical duration for not_applicable

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

First Submitted

Initial submission to the registry

May 24, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 31, 2017

Completed
4 months until next milestone

Study Start

First participant enrolled

October 1, 2017

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2019

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

October 3, 2017

Status Verified

September 1, 2017

Enrollment Period

1.8 years

First QC Date

May 24, 2017

Last Update Submit

September 30, 2017

Conditions

Capsular Contracture, Implant

Keywords

breast capsular contructure

Outcome Measures

Primary Outcomes (2)

  • reducing maximum capsular thickness (MCT)

    measured by ultrasound

    3.5 years

  • reduce pain

    pain assessed with visual analogue score (pain-VAS).

    3.5 years

Study Arms (1)

treatment group

EXPERIMENTAL

The treatment group will be injected with dexamethasone instracapsular under US according to our built protocol.

Drug: DexamethasoneDevice: US

Interventions

DexamethasoneDRUG

dexamethasone will be injected intracapsular under US

treatment group
USDEVICE

dexamethasone will be injected intracapsular under US

treatment group

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • female patient with grade 3-4 capsular contraction after alloplastic breast reconstruction\\ augmentation

You may not qualify if:

  • intake of steroids, anti-inflammatory, anti-coagulate or immunomodulatory medications on a regular basis
  • Patients with skin atrophy of the breast

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rabin Medical Center

Petah Tikva, IL, Israel

Location

MeSH Terms

Conditions

Implant Capsular Contracture

Interventions

Dexamethasone

Condition Hierarchy (Ancestors)

Foreign-Body ReactionInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsProsthesis FailurePostoperative Complications

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, Fluorinated

Study Officials

  • Muhammad Mansour, MD

    Rabin Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Muhammad Mansour, MD

CONTACT

972545717393‫Muhammad.dima@gmail.com‬

omri dominsky, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: one treatment group
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

May 24, 2017

First Posted

May 31, 2017

Study Start

October 1, 2017

Primary Completion

August 1, 2019

Study Completion

December 1, 2019

Last Updated

October 3, 2017

Record last verified: 2017-09

Data Sharing

IPD Sharing
Will share

Locations

IL(1)