Evaluation of Endoscopic Thyroidectomy Via Axillo-breast... | NCT04329455

Studies
Evaluation of Endoscopic Thyroidectomy Via Axillo-breast Approach in Thyroid Nodules

NCT04329455

Sponsor

Assiut University

Status

Unknown status

Last Update Posted

Apr 1, 2020Actual

Enrollment

30Estimated

Phase

Not provided

Conditions

Safety and Cosmetic Issues in Endoscopic Thyroidectomy

Interventions

Endoscopic thyroidectomy

Countries

Egypt

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

Mar 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 1, 2020Estimated

Primary Completion Date

Apr 1, 2022Estimated

Completion Date

Apr 1, 2023Estimated

First Submitted Date

Mar 30, 2020

First Submission Date that Met QC Criteria

Mar 30, 2020

First Posted Date

Apr 1, 2020Actual

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

Mar 30, 2020

Last Update Posted Date

Apr 1, 2020Actual

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

Evaluation of Endoscopic Thyroidectomy via Axillo-breast Approach in Thyroid Nodules regarding safety and cosmetic outcomes

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

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Intervention group			Procedure: Endoscopic thyroidectomy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Endoscopic thyroidectomy	Procedure	Endoscopic thyroidectomy in Thyroid Nodules	Intervention group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Safety of Endoscopic Thyroidectomy		2020_2023

Secondary Outcomes

Measure	Description	Time Frame
Cosmetic outcome of Endoscopic Thyroidectomy		2020_2023

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

benign thyroid nodules unilateral or bilateral Normal thyroid function

Exclusion Criteria:

malignant Thyroid Nodules Recurrent goitre Toxic goitre

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

30 patients age group 18_55 years with unilateral or bilateral thyroid nodules benign according to preoperative FNAC and normal thyroid function

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Ahmed Mohamed Gamal, MD	Contact	01069850499	71111	ahmedgamalgeneralsurgery@gmail.com
Ahmed Mohamed Gamal	Contact

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ahmed Gamal	Recruiting	Asyut		71111	Egypt

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided