NCT06472700

Brief Summary

  1. 1.A new surgical method for breast surgery has been introduced, which involves the removal of benign breast tumors through endoscopic surgery, thereby avoiding noticeable scarring on the breast.
  2. 2.The feasibility of this surgery, key technical points, and potential complications have been analyzed.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2021

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2023

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

June 15, 2024

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 25, 2024

Completed
Last Updated

June 25, 2024

Status Verified

June 1, 2024

Enrollment Period

1.9 years

First QC Date

June 15, 2024

Last Update Submit

June 23, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Cosmetic Outcome After Endoscopic Benign Breast Tumor Resection

    Through outpatient questionnaires and physician-rated photo evaluations

    1-3 months post-surgery.

Study Arms (1)

observation group

Other: No intervention

Interventions

No intervention

observation group

Eligibility Criteria

Age14 Years - 42 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

The study population consisted of patients diagnosed with benign breast tumors. The demographic characteristics included: Age: Patients aged 14-42 years old Gender: Female Ethnicity: Diverse ethnic backgrounds, primarily Han Chinese Inclusion Criteria: 1. Female breast benign tumor patients 2. Received endoscopic resection of benign breast tumors via a lateral chest wall approach. Exclusion Criteria: Patients who are unable to comply with follow-up requirements Sample Size: A total of 42 patients were included in the study Geographical Location: Patients were recruited from Sun Yat-sen Memorial Hospital of Sun Yat-sen University

You may qualify if:

  • Female breast benign tumor patients
  • Received endoscopic resection of benign breast tumors via a lateral chest wall approach.

You may not qualify if:

  • Patients who are unable to comply with follow-up requirements
  • Patients with a history of breast sugery
  • Breast cancer patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sun Yat-sen Memorial Hospital of Sun Yat-sen University

Guangzhou, Guangdong, 510000, China

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

June 15, 2024

First Posted

June 25, 2024

Study Start

October 1, 2021

Primary Completion

August 31, 2023

Study Completion

November 30, 2023

Last Updated

June 25, 2024

Record last verified: 2024-06

Locations