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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01409798
Other study ID # 0324-10-EP
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 9, 2010
Est. completion date April 27, 2015

Study information

Verified date August 2023
Source University of Nebraska
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The purpose of this registry is to create a database that collects clinical data to improve knowledge about primary hyperparathyroidism.


Description:

This will be a multi-institutional prospective study in which patients that have undergone parathyroidectomy with intra-operative PTH assessment. The success of minimally invasive parathyroidectomy without and with intra-operative PTH will be assessed for each patient. Success for exploration without intra-operative PTH will be defined as directed exploration with detection of an abnormal parathyroid in the location suggested by imaging. Success with intra-operative PTH will be defined as per standard protocols (50% or > decrease in intra-operative PTH following excision).


Recruitment information / eligibility

Status Completed
Enrollment 175
Est. completion date April 27, 2015
Est. primary completion date December 1, 2014
Accepts healthy volunteers No
Gender All
Age group 19 Years and older
Eligibility Inclusion Criteria: - Adult individuals (male and female) who have a personal diagnosis/history of primary hyperparathyroidism. - Age 19 or greater. - Patients who are seen and treated surgically at UNMC's Department of Otolaryngology- Head Neck Surgery . - Able to provide informed consent. Exclusion Criteria: -No history of primary hyperparathyroidism

Study Design


Locations

Country Name City State
United States University Of Missiouri Columbia Missouri
United States University of Iowa Iowa City Iowa
United States Kansas University Medical Center Lawrence Kansas
United States University of Minnesota Minneapolis Minnesota
United States University of Nebraska Medical Center Omaha Nebraska
United States Sanford School of Medicine Sioux Falls South Dakota

Sponsors (1)

Lead Sponsor Collaborator
University of Nebraska

Country where clinical trial is conducted

United States, 

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