Tokyo, July 3 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062117) titled 'A Prospective Observational Study to Evaluate the Safety of Implant-Based Breast Reconstruction with Prepectoral Placement in Breast Surgery' on July 2.
Study Type:
Observational
Primary Sponsor:
Institute - Cancer Institute Hospital of JFCR
Condition:
Condition - Breast Cancer: Hereditary Breast and Ovarian Cancer Syndrome
Classification by malignancy - Malignancy
Genomic information - NO
Objective:
Narrative objectives1 - This study aims to clarify the safety of placing tissue expanders or gel-filled breast implants in front of the pectoralis major muscle in patients undergoing nipple-sparing mastectomy.
Basic objectives2 - Safety
Eligibility:
Age-lower limit - 18
years-old
=
Gender - Male and Female
Key inclusion criteria - 1) Patients aged 18 to 75 years at the time of study enrollment;
2) Patients receiving outpatient treatment at this hospital;
3) Patients with clinical stage cTis, 1-2, N0 breast cancer or patients with hereditary breast and ovarian cancer syndrome (HBOC) who are scheduled for risk-reducing mastectomy (RRM)
4) Patients who wish to undergo minimally invasive breast surgery (endoscopic or robot-assisted nipple-sparing mastectomy) followed by postoperative breast reconstruction using implants
5) Patients with no extension or invasion into the nipple-areola complex (NAC) or the skin;
6) Patients who have obtained a skin flap thickness of 1 cm or more, or patients who have secured a breast skin flap thickness of 5 mm or more and are deemed to have no issues with skin blood flow as assessed by methods such as ICG fluorescence angiography;
7) patients who can tolerate general anesthesia
Key exclusion criteria - 1) Smokers (at the time consent is obtained)
2) Obese individuals (BMI of 30 or higher at the time consent is obtained)
3) Any other individuals deemed unsuitable by the physician
Target Size - 130
Recruitment Status:
Recruitment status - Open public recruiting
Date of protocol fixation - 2026 Year 06 Month 23 Day
Date of IRB - 2026 Year 07 Month 01 Day
Anticipated trial start date - 2026 Year 07 Month 02 Day
Last follow-up date - 2031 Year 12 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070971
Disclaimer: Curated by HT Syndication.
