MedTrace Logo

Aspen™ Ultrasound System and Aspen Rehabilitation Technique in the Treatment of Capsular Contracture

NCT02840084 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2021-06-15

No results posted yet for this study

Summary

Purpose: The purpose of this investigation is to test the safety and effectiveness of the Aspen System™ and Aspen Rehabilitation Technique. The device is intended for the therapeutic treatment of capsular contracture of the breast in conjunction with the Aspen Rehabilitation Technique. The hypothesis of the proposed study is that external ultrasound with the Aspen System™ device in conjunction with the Aspen Rehabilitation Technique is safe and effective in the reduction by at least one level of Baker Grade III capsular contracture in cosmetic breast augmentation patients, maintained at one year from the final treatment. Potential benefits of the study to subjects include improvement in the grade of capsular contracture of the breast without surgical treatment. The investigation is planned to last 12 months.

Conditions

  • Capsular Contracture of Breast, Grade III

Interventions

DEVICE

Aspen(TM) Ultrasound System

Two transducers per breast are applied. There will be 10 30 minute sessions, with 2 sessions per week for five weeks. The transducers will be placed on the medial and lateral positions of the affected breast, and then rotated to the superior and inferior aspects, and finally directly over the nipple-areolar complex. Following treatment, the affected breast will be massaged and bandaged per the Aspen Rehabilitation protocol, and the patient will be provided with home exercises as part of the Aspen Rehabilitation Technique. The treated breast(s) will be examined both prior to and immediately following each treatment session. To evaluate safety, any adverse events such as swelling, redness, or pain will be assessed. To determine efficacy, any change in the Baker Grade level will be assessed by physical examination. The breasts will be photographed prior to treatment at each visit to assist in evaluation of any visible change in the breasts.

Sponsors & Collaborators

  • Nina Naidu

    lead INDIV

Principal Investigators

  • Nina Naidu, MD · surgeon

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
22 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-09-15
Primary Completion
2021-06-10
Completion
2021-06-10
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02840084 on ClinicalTrials.gov