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NCT04428463
Fibrinogen- Based Collagen Fleece Graft Myringoplasty for Chronic Tympanic Membrane Perforations - a Prospective Study
NA trial testing Tachosil in Tympanic Membrane Perforation in 27 participants. Status unknown.
1 June 2021
Quick facts
| Lead sponsor | HaEmek Medical Center, Israel |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 27 |
| Start date | 30 June 2020 |
| Primary completion | 1 June 2021 |
| Estimated completion | 1 June 2021 |
Drugs / interventions tested
- Tachosil (THROMBIN) — full drug profile →
- fascia and cartilage
Conditions studied
- Tympanic Membrane Perforation — all drugs for Tympanic Membrane Perforation →
Sponsor
HaEmek Medical Center, Israel
Who can join
18 and older, any sex, with Tympanic Membrane Perforation. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
closure of tympanic membrane perforation
Time frame: one month after the procedure
one month post operative the patient will be re-examined in the clinic to see if the perforation is closed.
Sponsor's own description
Tympanic membrane perforations are common medical problem that encounters a lot of patients in all age groups. The gold standard for treatment of perforations is tympanic membrane closure procedure (tympanoplasty) which is done under general anesthesia. This procedure could be problematic for many patients who are not suitable for general anesthesia due to their medical status. It's also time consuming for the patient and for the medical system, since it takes a lot of time to reach the operation room and hospitalization for at least two days. The purpose in this study is to use Tachosil (Fibrinogen based patch) under local anesthesia to close tympanic membrane perforations. Tachosil is in use for hemostasis and for tissue repair after injury. Tachosil is bound to the tissue and form a waterproof membrane. In the setting of ENT clinic and under local anesthesia, the investigators will start the procedure with debridement of the tympanic perforation edges, then they will close the perforation using two pieces of Tachosil under and above the perforation in the right form (active side to the active side). If the results will be similar to tympanoplasty results, this method may be used for closure of tympanic perforation and save time and money for the patient and for the health system.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT04428463
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
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Related trials
Other trials of Tachosil
Trials testing the same drug.
- NCT03450265 — Hemopatch Compared to TachoSil in Postoperative Air Leak Duration After Pulmonary Resection · NA · completed
- NCT02685007 — RollOut -Pre-Rolled TachoSil in Laparoscopic Utilisation. A Non-Interventional Study · completed
Other recruiting trials for Tympanic Membrane Perforation
Currently open trials in the same condition.
- NCT05849844 — Tympanoseal Clinical Study · NA · recruiting
- NCT06260618 — Effect of Chitodex Gel in Tympanoplasty Surgery · NA · recruiting
Other HaEmek Medical Center, Israel trials
Trials by the same sponsor.
- NCT06656286 — Hysteroscopic Intrauterine Suturing · NA · not yet recruiting
- NCT06803992 — Induction of Labor - Comparison Propess With Prostaglandin E2 Vaginal Gel and Balloon Catheter · Phase 4 · recruiting
- NCT06542367 — Trans Canal Tympanoplasty With Local Anesthesia Using Fat Graft and "TachoSil" · NA · not yet recruiting
- NCT05732155 — Preliminary Effectiveness of Individual and Group MDMA-assisted Therapy for Israeli Veterans With PTSD and Moral Injury. · Phase 2 · unknown
- NCT05933018 — Night Hyperglycemia and Fatty Liver in Type 1 Diabetes · NA · unknown
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 NCT04428463 (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 HaEmek Medical Center, Israel
- Last refreshed: 11 June 2020
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/NCT04428463.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing