Evaluating Impact of Near Infrared Autofluorescence (NIRAF) Detection for Identifying Parathyroid Glands During Parathyroidectomy
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Michigan
- Enrollment
- 160
- Locations
- 1
- Primary Endpoint
- Average Number of Parathyroid Glands Identified
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Single (Participant)
Masking Description
Only participants will be masked to the intervention
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
PTeye
The surgeon will use the PTeye as an intraoperative tool to identify if a suspect tissue is a parathyroid or not, during the parathyroid surgery.
Intervention: PTeye (Device)
Standard of Care
The surgeon will rely solely on her/his surgical experience in identifying the parathyroid glands during the operations.
Intervention: Standard of Care (Other)
Outcomes
Primary Outcomes
Average Number of Parathyroid Glands Identified
Time Frame: Measured 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 Outcomes
- Parathyroid Hormone (PTH) Levels 5-14 Days After Surgery(5-14 days after surgery)
- Appropriate Intraoperative Parathyroid Hormone Drop(baseline to 10 minutes)
- Parathyroid Hormone (PTH) Levels 5-14 Days After Surgery(5-14 days after surgery)
- Appropriate Intraoperative Parathyroid Hormone Drop(baseline to 10 minutes)
- Duration of Surgery(Measured within the procedure, generally not more than 2 hours)
- Number of Nights Spent in the Hospital After Parathyroidectomy(0-72 hours after PTx procedure.)
- Number of Frozen Sections(Immediate)
Investigators
Paul Gauger
Ambulatory Care Clinical Chief, William J Fry Professor of Surgery and Professor of Surgery, Medical School
University of Michigan