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Core Study of the Safety and Effectiveness of IDEAL IMPLANT(R) Saline-filled Breast Implants

NCT00858052 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 500

Last updated 2021-09-30

No results posted yet for this study

Summary

The objective of this study is to determine the safety and effectiveness of the IDEAL IMPLANT in women who are undergoing primary breast augmentation or replacement of existing saline-filled or silicone gel-filled augmentation implants.

Conditions

  • Breast Implants

Interventions

DEVICE

Saline-filled breast implant [IDEAL IMPLANT (R)]

Breast augmentation

Sponsors & Collaborators

  • Ideal Implant Incorporated

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-02-28
Primary Completion
2012-02-29
Completion
2021-05-31

Countries

  • United States

Study Locations

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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 NCT00858052 on ClinicalTrials.gov