"Parathyroid Tissues Anatomic Localizations Are Displaced... | NCT02636075

Studies
"Parathyroid Tissues Anatomic Localizations Are Displaced Downward in Parathyroid Hyperplasia Cases"

NCT02636075

Sponsor

SB Istanbul Education and Research Hospital

Status

Unknown status

Last Update Posted

Dec 21, 2015Estimated

Enrollment

125Actual

Phase

Not provided

Conditions

Parathyroid Hyperplasia

Interventions

Not provided

Countries

Not provided

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

Dec 2015

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Enrolling by invitation

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2015

Primary Completion Date

Jan 2016Estimated

Completion Date

Feb 2016Estimated

First Submitted Date

Dec 5, 2015

First Submission Date that Met QC Criteria

Dec 18, 2015

First Posted Date

Dec 21, 2015Estimated

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

Dec 18, 2015

Last Update Posted Date

Dec 21, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Erhan Aysan, Head of the Department of General Surgery, SB Istanbul Education and Research HospitalPrincipal Investigator

Lead Sponsor

SB Istanbul Education and Research HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

This study investigates if Parathyroid Tissues Anatomic Localizations Are Displaced Downward in Parathyroid Hyperplasia Cases or not.

Detailed Description

Parathyroid tissues gets heavier when they become Hyperplasia. Because of this weight change, they change their normal anatomic positions. 125 patients who have been operated earlier will be included in the study.

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

125Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Size of the thyroid tissue	Longitudinal size (in mm) of each parathyroid tissue according to its anatomical location (upper, middle or lower 1/3 of the thyroid gland or below the thyroid)	one year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients who have undergone an operation due to parathyroid hyperplasia

Exclusion Criteria:

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

no limitaion

Sampling Method

Probability Sample

Label	Type	Description	Intervention Names
Upper 1/3 of thyroid tissue
Middle 1/3 of thyroid tissue
Lower 1/3 of thyroid tissue
Below thyroid tissue