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Endoscopic vs Conventional Mastectomy for Breast Cancer Wound Complications

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Summary

NIH's ClinicalTrials.gov has registered a new randomized, open-label study comparing endoscopic skin-sparing mastectomy (E-SSM) with conventional mastectomy (CM) in 258 female patients with unilateral invasive breast cancer (T1-4aN0-3M0). The trial will enroll 129 participants per arm across multiple centers and randomize by site, with primary endpoints including postoperative wound complications and patient satisfaction. This registry entry documents the trial's design, eligibility criteria (breast volume ≤ cup C, grade I-II ptosis), and dual interventions.

“This randomized, open-label study compares endoscopic skin-sparing mastectomy (E-SSM) with conventional mastectomy (CM) in female patients with unilateral invasive breast cancer (T1-4aN0-3M0).”

NIH , verbatim from source
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About this source

ClinicalTrials.gov is the NIH-run registry of every clinical trial conducted in the United States, plus most international trials sponsored by US-based companies or institutions. By federal law, sponsors must register Phase 2 through Phase 4 studies before enrolling patients and post results within a year of completion. This feed tracks every new trial registration and study update, around 700 a month: drug interventions, device studies, behavioral protocols, observational research. Watch this if you scout drug candidates moving into mid or late-stage development, monitor competitor pipelines, or follow rare disease research where new trials signal patient hope. GovPing parses sponsor, phase, intervention, and target indication on each entry.

What changed

This ClinicalTrials.gov registry entry documents a newly registered randomized clinical trial (NCT07548762) comparing endoscopic skin-sparing mastectomy with conventional mastectomy for breast cancer. The study will enroll 258 female participants across multiple centers, randomized equally between the two surgical approaches. Primary outcomes include postoperative wound complications and patient satisfaction; secondary outcomes include breast appearance and oncological safety.

For healthcare providers and clinical investigators, this registry entry signals an emerging comparative-effectiveness study in breast cancer surgery that may inform future surgical practice guidelines. Facilities with breast cancer surgery programs should note the specific patient eligibility criteria (T1-4aN0-3M0 staging, breast volume ≤ cup C, grade I-II ptosis) when considering patient referrals or internal practice alignment.

Archived snapshot

Apr 24, 2026

GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.

← ClinicalTrials.gov Studies

Endoscopic Skin-Sparing vs. Conventional Mastectomy for Wound Complications in BC

N/A NCT07548762 Kind: NA Apr 23, 2026

Abstract

This randomized, open-label study compares endoscopic skin-sparing mastectomy (E-SSM) with conventional mastectomy (CM) in female patients with unilateral invasive breast cancer (T1-4aN0-3M0). The primary objective is to evaluate differences in postoperative wound complications and patient satisfaction, with secondary outcomes including breast appearance and oncological safety.

Eligible patients have a breast volume ≤ cup C and no/mild ptosis (grade I-II). A total of 258 participants (129 per group) will be enrolled across multiple centers and randomized by site.

This study aims to provide evidence for selecting optimal endoscopic surgical strategies, address the evidence gap for E-SSM without immediate reconstruction, and advance the precision of breast cancer surgery.

Conditions: Breast Cancer

Interventions: Endoscopic skin-sparing mastectomy, Conventional mastectomy

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Last updated

Classification

Agency
NIH
Published
April 23rd, 2026
Instrument
Notice
Branch
Executive
Legal weight
Non-binding
Stage
Final
Change scope
Minor
Docket
NCT07548762

Who this affects

Applies to
Clinical investigators Healthcare providers
Industry sector
6211 Healthcare Providers
Activity scope
Clinical trial registration Surgical procedure research Medical device evaluation
Threshold
breast volume ≤ cup C; no/mild ptosis (grade I-II); T1-4aN0-3M0 staging
Geographic scope
United States US

Taxonomy

Primary area
Healthcare
Operational domain
Clinical Operations
Topics
Medical Devices Clinical Operations

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