NCT04509011

Brief 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

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
516

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2021

Typical duration for not_applicable

Geographic Reach
4 countries

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 4, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 11, 2020

Completed
5 months until next milestone

Study Start

First participant enrolled

January 5, 2021

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2022

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2023

Completed
Last Updated

November 15, 2024

Status Verified

November 1, 2024

Enrollment Period

1.7 years

First QC Date

August 4, 2020

Last Update Submit

November 13, 2024

Conditions

Hypoparathyroidism Postprocedural

Keywords

HypoparathyroidismPTHHypocalcemia

Outcome Measures

Primary Outcomes (1)

  • Postoperative level of Parathyroid hormone (PTH)

    Low plasma parathyroid hormone (PTH) (below the normal reference range)

    First postoperative day

Secondary Outcomes (8)

  • Postoperative medication with Active vitamin D

    At discharge (up to 7 days), at 1 month and at 6 months

  • Postoperative medication with oral calcium

    At discharge (up to 7 days), at 1 month and at 6 months

  • Identification of parathyroid glands

    Intraoperatively

  • Autotransplantation of parathyroid tissue

    Intraoperatively

  • Excised parathyroid glands

    One week

  • +3 more secondary outcomes

Study Arms (2)

Fluobeam® LX

EXPERIMENTAL

Fluobeam® LX is used to detect autofluorescens and identify and evaluate parathyroid glands

Device: Fluobeam® LX

Control

NO INTERVENTION

In the control group, the parathyroid glands are identified and evaluated by eye (ocular examination).

Interventions

Fluobeam® LXDEVICE

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

Fluobeam® LX

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with thyroid disease planned for total thyroidectomy regardless of diagnosis

You may not qualify if:

  • Previous thyroid surgery
  • Previous parathyroid surgery
  • Concurrent parathyroid surgery
  • Renal insufficiency
  • Pregnancy
  • Breast feeding
  • Allergy (contrast agent, iodine)
  • Inability to understand study information
  • Patient unable to participate in planned follow-up program

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Rudolfstiftung

Vienna, 1030, Austria

Location

Haukeland University Hospital

Bergen, 5021, Norway

Location

Jagiellonian University Medical College

Krakow, 31-008, Poland

Location

Sahlgrenska University Hospital

Gothenburg, 41345, Sweden

Location

Skåne University Hospital, Department of Surgery, Lund

Lund, 22185, Sweden

Location

Related Publications (1)

  • Bergenfelz A, Barczynski M, Heie A, Muth A, Passler C, Schneider M, Wierzbicka P, Konturek A, Brauckhoff K, Elf AK, Dahlberg J, Hermann M. Impact of autofluorescence for detection of parathyroid glands during thyroidectomy on postoperative parathyroid hormone levels: parallel multicentre randomized clinical trial. Br J Surg. 2023 Nov 9;110(12):1824-1833. doi: 10.1093/bjs/znad278.

    PMID: 37758507DERIVED

MeSH Terms

Conditions

HypoparathyroidismHypocalcemia

Condition Hierarchy (Ancestors)

Parathyroid DiseasesEndocrine System DiseasesCalcium Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesWater-Electrolyte Imbalance

Study Officials

  • Anders OJ Bergenfelz, PhD

    Skane University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
The participant is not informed of the assigned group, whereas the the care giver (surgeon) is informed due to the use (or not) of the Fluobeam®-LX. Randomization is performed 1: 1 in blocks of 10 via the Eurocrine quality register platform.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Intervention group (intraoperative use of Fluobeam®-LX during thyroid surgery) Control group (clinical assessment and identification of parathyroid glands during thyroid surgery)
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 4, 2020

First Posted

August 11, 2020

Study Start

January 5, 2021

Primary Completion

October 1, 2022

Study Completion

July 31, 2023

Last Updated

November 15, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will share

All individual participant data (IPD) that underlie results in a publication. Individuals are de-identified

Shared Documents
STUDY PROTOCOL
Time Frame
Starting 12 months after publication and for five years
Access Criteria
Researchers within the medical community The principal investigator or the Central Contact Backup will review requests.

Locations

NO(1)SE(2)AU(1)PL(1)