Trials / Not Yet Recruiting
Not Yet RecruitingNCT07473830
PANDORA: Evaluation of Platelet-rich Plasma in Non-tumoural Odour Disorders: a Descriptive Pilot Study.
- Status
- Not Yet Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- Sponsor
- Hospices Civils de Lyon · Academic / Other
- Sex
- All
- Age
- 18 Years – 99 Years
- Healthy volunteers
- Not accepted
Summary
This is a prospective, single-center, single-arm, non-comparative descriptive pilot study evaluating autologous platelet-rich plasma (PRP) injections in adults with persistent (\>6 months) non-tumoural olfactory dysfunction, either age-related degenerative olfactory dysfunction (DOD) or post-traumatic olfactory dysfunction (DOPT). Participants receive three PRP injections over 4 weeks (Day 0, Day 14, Day 28), with follow-up visits at Month 3 and Month 6 after the first injection. Olfactory function is assessed using the Sniffin' Sticks Test (TDI score). Patient-reported outcomes include SNOT-22 and a visual analog scale (VAS) for perceived olfactory impairment. Safety is assessed through adverse event collection.
Detailed description
Prospective consecutive recruitment in an ENT department at Hôpital Lyon Sud (Hospices Civils de Lyon). Eligible participants are enrolled into one of two diagnostic cohorts (DOD or DOPT), and analyses are performed separately by cohort. PRP is prepared from autologous venous blood using a standardized preparation system and injected under endoscopic guidance in the olfactory cleft area (superior nasal septum mucosa). Follow-up assessments are performed at baseline and at Months 3 and 6 after the first injection.
Conditions
- Olfactory Dysfunction
- Post-traumatic Olfactory Dysfunction
- Age-related Degenerative Olfactory Dysfunction
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Autologous Platelet-Rich Plasma (PRP) Injection | At each injection visit (Day 0, Day 14 ±1, Day 28 ±1), venous blood is collected and processed to obtain autologous PRP using a standardized preparation system. PRP is injected under endoscopic guidance into the superior nasal septum mucosa near the olfactory cleft, up to a total volume of 4 mL per visit. Participants are monitored after each injection and adverse events are recorded. |
Timeline
- Start date
- 2026-05-01
- Primary completion
- 2028-05-01
- Completion
- 2028-05-01
- First posted
- 2026-03-16
- Last updated
- 2026-03-20
Locations
1 site across 1 country: France
Source: ClinicalTrials.gov record NCT07473830. Inclusion in this directory is not an endorsement.