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Autofluorescence vs Clinical Assessment of Parathyroid Glands During Thyroid Surgery

NCT04509011 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 516

Last updated 2024-11-15

No results posted yet for this study

Summary

The purpose of the investigation is to study if the use of Fluobeam®-LX to identify parathyroid glands through autofluorescence during thyroid surgery, may reduce the risk of postoperative hypoparathyroidism, defined as low PTH in patients undergoing total thyroidectomy

Conditions

  • Hypoparathyroidism Postprocedural

Interventions

DEVICE

Fluobeam® LX

Fluobeam®-LX is used to identify and evaluate parathyroid glands using auto-fluorescence during thyroid surgery.

Sponsors & Collaborators

  • Haukeland University Hospital

    collaborator OTHER

  • Jagiellonian University

    collaborator OTHER

  • Sahlgrenska University Hospital

    collaborator OTHER

  • Hospital Rudolfstiftung

    collaborator OTHER

  • Region Skane

    lead OTHER

Principal Investigators

  • Anders OJ Bergenfelz, PhD · Skane University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-05
Primary Completion
2022-10-01
Completion
2023-07-31

Countries

  • Austria
  • Norway
  • Poland
  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04509011 on ClinicalTrials.gov