NCT02901873

Brief Summary

Parathyroid glands are involved in calcium metabolism and their damage during neck surgery results in 'hypoparathyroidism', a condition characterized by 'low blood calcium' levels; this is associated with significant short and long term morbidity. There are four parathyroid glands in the neck which can vary in size and location. They can be mistaken for lymph nodes, fat or thyroid nodules. A normal parathyroid gland is the size of a small pea and is often difficult to recognize during surgery; making it susceptible to inadvertent injury or removal. Thyroid and parathyroid surgery are commonly performed in the UK. Prompt and accurate identification of parathyroid tissue during surgery reduces the likelihood of hypoparathyroidism. However, this complication is still common. Research exploring the use of intraoperative technologies to enable early identification and preservation of normal parathyroid glands during surgery is ongoing. Electrical impedance spectroscopy (EIS) is one such technology. ZedScanTM is a handheld device that measures electrical impedance of tissues. It is currently used as a adjunct during colposcopy in cervical cancer screening. The device has a CE mark for this purpose and is safe to use in humans. We have already demonstrated that electrical impedance spectroscopy can detect differences in cellular structure and differentiate between tissues in the rabbit neck. We now aim to demonstrate the feasibility of using this technology (ZedScanTM) in humans. This has potential to be used in thyroid and parathyroid surgery to differentiate parathyroid glands from other structures; thereby decreasing their damage and the risk of post surgical hypothyroidism.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
56

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2016

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

June 27, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 12, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 15, 2016

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 27, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 27, 2017

Completed
Last Updated

September 11, 2018

Status Verified

September 1, 2018

Enrollment Period

1 year

First QC Date

September 12, 2016

Last Update Submit

September 7, 2018

Conditions

ThyroidectomyParathyroid Diseases

Outcome Measures

Primary Outcomes (1)

  • generation of electrical impedance spectral curves (EI across the range of frequencies) for thyroid, parathyroid, muscle, lymph nodes and adipose tissues

    single surgery

Study Arms (2)

Thyroid surgery

ACTIVE COMPARATOR

Electrical Impedance Spectroscopy in Thyroid surgery

Device: Electrical Impedance Spectroscopy

Parathyroid surgery

ACTIVE COMPARATOR

Electrical Impedance Spectroscopy in parathyroid surgery

Device: Electrical Impedance Spectroscopy

Interventions

Electrical Impedance SpectroscopyDEVICE
Parathyroid surgeryThyroid surgery

Eligibility Criteria

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

You may not qualify if:

  • \- Patients undergoing thyroglossal cyst surgery, re-do procedures only involving resection of lymph nodes
  • Patients unable to understand spoken and written English
  • Patients unable to give adequate informed consent
  • Patients with a positive pre-operative pregnancy test

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Royal Hallamshire Hospital

Sheffield, South Yorkshire, S10 2JF, United Kingdom

Location

Related Publications (1)

  • Hillary SL, Brown BH, Brown NJ, Balasubramanian SP. Use of Electrical Impedance Spectroscopy for Intraoperative Tissue Differentiation During Thyroid and Parathyroid Surgery. World J Surg. 2020 Feb;44(2):479-485. doi: 10.1007/s00268-019-05169-7.

    PMID: 31511942DERIVED

MeSH Terms

Conditions

Parathyroid Diseases

Condition Hierarchy (Ancestors)

Endocrine System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 12, 2016

First Posted

September 15, 2016

Study Start

June 27, 2016

Primary Completion

June 27, 2017

Study Completion

June 27, 2017

Last Updated

September 11, 2018

Record last verified: 2018-09

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)