Ignite Creation Date:
2025-12-26 @ 11:08 AM
Ignite Modification Date:
2025-12-31 @ 1:13 PM
Study NCT ID:
NCT01000012
Status:
NO_LONGER_AVAILABLE
Last Update Posted:
2013-10-29
First Post:
2009-10-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Compassionate Use of the Becker Expander/Breast Implant
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D018427', 'term': 'Breast Implants'}], 'ancestors': [{'id': 'D019736', 'term': 'Prostheses and Implants'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}]}}, 'protocolSection': {'designModule': {'studyType': 'EXPANDED_ACCESS', 'nPtrsToThisExpAccNctId': 1}, 'statusModule': {'overallStatus': 'NO_LONGER_AVAILABLE', 'statusVerifiedDate': '2013-10', 'lastUpdateSubmitDate': '2013-10-28', 'studyFirstSubmitDate': '2009-10-21', 'studyFirstSubmitQcDate': '2009-10-21', 'lastUpdatePostDateStruct': {'date': '2013-10-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-10-22', 'type': 'ESTIMATED'}}, 'conditionsModule': {'conditions': ['Breast Reconstruction']}, 'descriptionModule': {'briefSummary': "To provide access of the Becker Expander/Breast implant to women who do not meet inclusion/exclusion criteria of the Becker Continued Access Study\n\nPatients' physician will contact Mentor to request use of the device and each request will be reviewed by Mentor, an IRB, and the FDA on a case-by-case basis"}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women who require a Becker Expander/Breast implant who do not meet inclusion/exclusion criteria of the Becker Continued Access Study'}, 'identificationModule': {'nctId': 'NCT01000012', 'briefTitle': 'Compassionate Use of the Becker Expander/Breast Implant', 'organization': {'class': 'INDUSTRY', 'fullName': 'Mentor Worldwide, LLC'}, 'officialTitle': 'Compassionate Use of the Becker Expander/Breast Implant', 'orgStudyIdInfo': {'id': 'A101-0501-08cu'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Becker 50 Expander/Breast implant', 'type': 'DEVICE', 'description': 'The breast implant is comprised of the Becker implant and the injection dome/fill tube and has a low bleed, gel-filled outer lumen and an adjustable saline-fillable inner lumen. The inner lumen can be gradually filled with saline over an extended period of time via the fill tube by injecting saline through the injection dome. Once expanded to the desired volume, the fill tube and injection dome are removed through a small incision under local anesthetic, and the prosthesis remains in position as a breast implant.\n\nThe Becker 50 Expander/Breast Implant has a 50% gel volume and a 50% saline volume, so a 400cc implant would nominally have 200cc of saline and 200cc of silicone. The Becker 50 Expander/Breast Implant is available in sizes from 300 to 700cc.'}, {'name': 'Becker 25 Expander/Breast implant', 'type': 'DEVICE', 'description': 'The breast implant is comprised of the Becker implant and the injection dome/fill tube and has a low bleed, gel-filled outer lumen and an adjustable saline-fillable inner lumen. The inner lumen can be gradually filled with saline over an extended period of time via the fill tube by injecting saline through the injection dome. Once expanded to the desired volume, the fill tube and injection dome are removed through a small incision under local anesthetic, and the prosthesis remains in position as a breast implant.\n\nThe Becker 25 Expander/Breast Implant has a silicone gel volume of approximately 25% and saline volume of approximately 75%. The Becker Expander/Breast Implant is available in sizes 150 - 800cc.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '93111', 'city': 'Santa Barbara', 'state': 'California', 'country': 'United States', 'facility': 'Mentor Worldwide LLC', 'geoPoint': {'lat': 34.42083, 'lon': -119.69819}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mentor Worldwide, LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}