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NCT05117853
Autofluorescence and Indocyanine Green to Avoid Hypocalcemia After Thyroidectomy
Phase 3 trial testing Autofluorescent detection + Injection of indocyanine green in Thyroid Disease in 300 participants. Currently enrolling.
31 October 2024
Quick facts
| Lead sponsor | Onze Lieve Vrouw Hospital |
|---|---|
| Phase | Phase 3 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | prevention |
| Enrollment | 300 |
| Start date | 1 November 2021 |
| Primary completion | 31 October 2024 |
| Estimated completion | 31 May 2025 |
| Sites | 1 location across Belgium |
Drugs / interventions tested
- Autofluorescent detection + Injection of indocyanine green — full drug profile →
- Gold standard of visual identification and evaluation of viability of the parathyroid glands.
Conditions studied
- Thyroid Disease — all drugs for Thyroid Disease →
- Hypoparathyroidism Postprocedural — all drugs for Hypoparathyroidism Postprocedural →
Sponsor
Onze Lieve Vrouw Hospital
Who can join
18 and older, any sex, with Thyroid Disease or Hypoparathyroidism Postprocedural. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
* Hypoparathyroidism (and the resulting hypocalcemia) remains the most common morbidity after a total thyroidectomy. * The identification and preservation of parathyroid glands during neck surgery has always been challenging but is crucial to avoid postoperative hypocalcemia. * Recently, the specific autofluorescent characteristics of endogenous fluorophores in the parathyroid tissue have been used to detect and confirm parathyroid glands during thyroid surgery. * Injecting indocyanine green and using its fluorescent characteristics has the advantage of adding information about the vascular supply of the parathyroid glands. * This randomized clinical trial aims to investigate whether using autofluorescence and indocyanine green during thyroid surgery can predict or prevent postoperative hypocalcemia.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05117853
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Thyroid Disease
Currently open trials in the same condition.
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- NCT07294989 — The Effective Blood Concentration of Ciprofol · recruiting
- NCT06296420 — Dysphagia After Thyroidectomy · recruiting
Other Onze Lieve Vrouw Hospital trials
Trials by the same sponsor.
- NCT05231161 — Diagnostic Performance of Exercise Stress Tests for the Detection of Epicardial and Microvascular Coronary Artery Diseas · completed
- NCT03782688 — Precise Percutaneous Coronary Intervention Plan (P3) Study · completed
- NCT03778749 — Electromyography and Acceleromyography in Ventilated ICU Patients · NA · terminated
- NCT03665805 — Postoperative Residual Curarization in 2018 · completed
- NCT03824600 — Physiological Patterns of Coronary Artery Disease · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05117853 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Onze Lieve Vrouw Hospital
- Last refreshed: 5 April 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05117853.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing