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

Not Applicable
Completed
Conditions
Parathyroid Cancer
Hypercalcemia
Parathyroid Adenoma
Primary Hyperparathyroidism
Parathyroid Neoplasms
Registration Number
NCT05022641
Lead Sponsor
University of Michigan
Brief Summary

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.

Detailed Description

Prior to data collection, it was determined some additional outcome measures collected by the primary site would not be relevant to the trial for participating sites such as this site. Those outcomes were removed from this record.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
160
Inclusion Criteria
  • Primary hyperparathyroidism who will be undergoing parathyroid surgery
  • Persistent primary hyperparathyroidism after having undergone a failed prior parathyroid surgery who will be undergoing repeat parathyroid surgery
Exclusion Criteria
  • 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.)
  • Patients with concurrent parathyroid and thyroid disease that require total thyroidectomy
  • Patients with secondary or tertiary hyperparathyroidism

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Average Number of Parathyroid Glands IdentifiedMeasured within the procedure, generally not more than 2 hours

Average number of parathyroid glands identified between the Experimental Group: Glands identified with naked eye + NIRAF vs. the Control Group: Glands identified with naked eye.

Secondary Outcome Measures
NameTimeMethod
Parathyroid Hormone (PTH) Levels 5-14 Days After Surgery5-14 days after surgery

Parathyroid hormone (PTH) levels 5-14 days after surgery. Higher levels could indicate failure of operation. Low levels could indicate temporary or permanent parathyroid damage.

Appropriate Intraoperative Parathyroid Hormone Dropbaseline to 10 minutes

\>50% drop from baseline at 10 minutes post-resection

Duration of Surgery in MinutesMeasured within the procedure, generally not more than 2 hours

Surgery duration in minutes

Number of Nights Spent in the Hospital After Parathyroidectomy0-72 hours after PTx procedure

Number of nights spent for postoperative recovery in the hospital after the surgical procedure.

Number of Frozen Sectionstotal number of frozen sections sent to confirm parathyroid gland identity, immediate.

Total number of frozen sections conducted for patients undergoing repeat surgery or bilateral neck explorations. Frozen sections were conducted to confirm that the parathyroid tissue for the targeted over-acting parathyroid was removed. Results reflect whether participants had a frozen section conducted.

Trial Locations

Locations (1)

The University of Michigan

🇺🇸

Ann Arbor, Michigan, United States

The University of Michigan
🇺🇸Ann Arbor, Michigan, United States
Hunter Underwood
Contact
734-936-0231
hunder@umich.edu
Paul Gauger
Principal Investigator

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