Endoscopic Extirpation of Benign Breast Tumors Using a La... | NCT06472700

Studies
Endoscopic Extirpation of Benign Breast Tumors Using a Lateral Chest Wall Incision

NCT06472700

Sponsor

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Status

Completed

Last Update Posted

Jun 25, 2024Actual

Enrollment

42Actual

Phase

Not provided

Conditions

Endoscopic Breast Surgery
Benign Breast Tumors

Interventions

No intervention

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 1, 2021Actual

Primary Completion Date

Aug 31, 2023Actual

Completion Date

Nov 30, 2023Actual

First Submitted Date

Jun 15, 2024

First Submission Date that Met QC Criteria

Jun 23, 2024

First Posted Date

Jun 25, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 23, 2024

Last Update Posted Date

Jun 25, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.
The feasibility of this surgery, key technical points, and potential complications have been analyzed.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

42Actual

Label	Type	Description	Intervention Names
observation group			Other: No intervention

Name	Type	Description	Arm Group Labels	Other Names
No intervention	Other	No intervention	observation group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Cosmetic Outcome After Endoscopic Benign Breast Tumor Resection	Through outpatient questionnaires and physician-rated photo evaluations	1-3 months post-surgery.

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Female breast benign tumor patients
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
Patients with a history of breast sugery
Breast cancer patients

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

14 Years

Maximum Age

42 Years

Standard Ages

ChildAdult

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:

Female breast benign tumor patients
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

Sampling Method

Non-Probability Sample