NCT01060982

Brief Summary

This study is a multicentre, open, uncontrolled trial for the observation of histological changes in parathyroid adenomas following high intensity focused ultrasound (HIFU). This study will be conducted in France in 10 patients with primary hyperparathyroidism scheduled for a parathyroidectomy. The patient will receive an HIFU treatment in the center of the adenoma before the surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
5

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2010

Typical duration for not_applicable

Geographic Reach
1 country

2 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

February 1, 2010

Completed
Same day until next milestone

Study Start

First participant enrolled

February 1, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 2, 2010

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
Last Updated

May 6, 2014

Status Verified

May 1, 2014

Enrollment Period

2.9 years

First QC Date

February 1, 2010

Last Update Submit

May 5, 2014

Conditions

Primary Parathyroid Adenomas

Keywords

Primary hyperparathyroidismHigh Intensity Focused UltrasoundParathyroid tumorParathyroid hormoneCalcium

Outcome Measures

Primary Outcomes (1)

  • Histology of excised gland.

    After surgery performed the same day as High intensity focused ultrasound treatment

Study Arms (1)

HIFU treatment

EXPERIMENTAL
Device: Ultrasonic ablation device

Interventions

Ultrasonic ablation deviceDEVICE

One High Intensity focused ultrasound session before surgery. Use of appropriate energy for each patient

Also known as: TH-One
HIFU treatment

Eligibility Criteria

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

You may qualify if:

  • Male or female patient 18 years or older.
  • Patients with diagnosed primary hyperparathyroidism (clinical symptoms and/or biochemical disturbances) scheduled for parathyroidectomy.
  • One diseased parathyroid gland, visualized by ultrasonography.
  • The diseased targeted parathyroid gland accessible for HIFU treatment (anonymised ultrasonographic images to be sent to the sponsor's technical team for validation).
  • Normal pretreatment nasofibroscopy.
  • Voluntary signed informed consent.

You may not qualify if:

  • Inaccessibility or high risk of targeting neighbouring structures, as evidenced by:
  • Targeted area located less than 2 mm laterally from the oesophagus or the carotid artery
  • Targeted area located less than 3 mm laterally from the trachea,
  • Significant hyperechoic area with a posterior shadow located less than 10 mm behind the targeted area (behind to be understood as posterior to the targeted area in the direction of the HIFU beam)
  • Investigator appreciation of any abnormal blood test that could contraindicate treatment with HIFU (bleeding abnormalities)
  • Known spondylitis of the neck vertebrae
  • Head and/or neck disease that prevents hyperextension of neck.
  • Known history of parathyroid or other neoplasias in the neck region.
  • History of neck irradiation
  • Patients whose concurrent illnesses, disability, or geographical residence would hamper attendance at required study visit
  • Pregnant or lactating woman.
  • Female patient of childbearing age if not having a suitable contraception method.
  • Patients who have received any investigational drug or device within the last 15 days and/or patients who are currently participating in another clinical trial.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hôpital Privé des Peupliers

Paris, 75013, France

Location

Cochin Hospital

Paris, 75014, France

Location

MeSH Terms

Conditions

Hyperparathyroidism, PrimaryParathyroid Neoplasms

Condition Hierarchy (Ancestors)

HyperparathyroidismParathyroid DiseasesEndocrine System DiseasesEndocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck Neoplasms

Study Officials

  • Philippe BONNICHON, MD

    Cochin Hospital, Paris, Fance

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 1, 2010

First Posted

February 2, 2010

Study Start

February 1, 2010

Primary Completion

January 1, 2013

Study Completion

January 1, 2013

Last Updated

May 6, 2014

Record last verified: 2014-05

Locations

FR(2)