NCT04785443 Contribution of ICG Angiography in the Detection of Parathyroids and the Prevention of Hypoparathyroidism Post Total Thyroidectomy
| NCT ID | NCT04785443 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | University Hospital, Brest |
| Condition | Thyroid Diseases |
| Study Type | INTERVENTIONAL |
| Enrollment | 242 participants |
| Start Date | 2021-06-22 |
| Primary Completion | 2026-06-22 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 242 participants in total. It began in 2021-06-22 with a primary completion date of 2026-06-22.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
* Hypoparathyroidism is the most common complication after a total thyroidectomy surgery. It becomes permanent after 6 months. * Untreated permanent hypoparathyroidism is a source of numerous complications in general and therefore requires lifelong replacement therapy resulting in a significant deterioration in quality of life. * The intraoperative use of indocyanine green (ICG) angiography has recently been described as a reliable means of detecting parathyroidism and predicting the risk of postoperative hypoparathyroidism. * This use could prove to be a way to preserve parathyroid in vivo and thus reduce post-operative hypoparathyroidism rates.
Eligibility Criteria
Inclusion Criteria: * Patient having to undergo a total thyroidectomy * Signed consent * Patient beneficiary of a social security regimen Exclusion Criteria: * Minor patient under 18 years old * Major patient protected by law or unable to give informed consent * Pregnant or breastfeeding woman * Thyroidectomy totalization * History of thyroid or parathyroid surgery * Participation refusal * Known allergy to ICG * Woman of child-bearing age not using adequate method of contraception
Contact & Investigator
Jean-Christophe LECLERE, PhD
PRINCIPAL INVESTIGATOR
CHRU de Brest
Frequently Asked Questions
Who can join the NCT04785443 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Thyroid Diseases. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04785443 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 242 participants.
Is NCT04785443 currently recruiting?
Yes, NCT04785443 is actively recruiting participants. Contact the research team at jean-christophe.leclere@chu-brest.fr for enrollment information.
Where is the NCT04785443 trial being conducted?
This trial is being conducted at Brest, France.
Who is sponsoring the NCT04785443 clinical trial?
NCT04785443 is sponsored by University Hospital, Brest. The principal investigator is Jean-Christophe LECLERE, PhD at CHRU de Brest. The trial plans to enroll 242 participants.