COMPLETED

Evaluating Impact of Near Infrared Autofluorescence (NIRAF) Detection for Identifying Parathyroid Glands During Parathyroidectomy

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This study will see if the use of near infrared autofluorescence (NIRAF) detection with an FDA-cleared device 'Parathyroid Eye (PTeye)' for identifying parathyroid glands (PGs) during parathyroidectomy (PTx) procedures is better than a surgeon's detection alone. It compares risk-benefits and outcomes in PTx patients where NIRAF detection with PTeye for parathyroid identification is either used or not used. Parathyroidectomy - look at application of the technology to see if it assists during a parathyroidectomy.

Official Title

Evaluating Impact of Near Infrared Autofluorescence (NIRAF) Detection for Identifying Parathyroid Glands During Parathyroidectomy

Quick Facts

Study Start:2021-12-01
Study Completion:2024-05-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT05022641

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Primary hyperparathyroidism who will be undergoing parathyroid surgery
  2. * Persistent primary hyperparathyroidism after having undergone a failed prior parathyroid surgery who will be undergoing repeat parathyroid surgery
  1. * Pregnant women (Those patients who could potentially will receive preoperative pregnancy testing, as is standard before general anesthesia. Any patients with positive pregnancy test results will not be included in the study.)
  2. * Patients with concurrent parathyroid and thyroid disease that require total thyroidectomy
  3. * Patients with secondary or tertiary hyperparathyroidism

Contacts and Locations

Principal Investigator

Paul Gauger
PRINCIPAL_INVESTIGATOR
University of Michigan

Study Locations (Sites)

The University of Michigan
Ann Arbor, Michigan, 48109
United States

Collaborators and Investigators

Sponsor: University of Michigan

  • Paul Gauger, PRINCIPAL_INVESTIGATOR, University of Michigan

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-12-01
Study Completion Date2024-05-31

Study Record Updates

Study Start Date2021-12-01
Study Completion Date2024-05-31

Terms related to this study

Keywords Provided by Researchers

  • Parathyroidectomy
  • Intraoperative Parathyroid Identification
  • Near Infrared Autofluorescence
  • Persistent Hyperparathyroidism
  • Persistent Hypercalcemia
  • Failed Parathyroidectomy
  • Repeat Parathyroidectomy

Additional Relevant MeSH Terms

  • Parathyroid Adenoma
  • Parathyroid Neoplasms
  • Parathyroid Cancer
  • Hypercalcemia
  • Primary Hyperparathyroidism