Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT04279236 · ClinicalTrials.gov registry record
Multi-Center Study on Performance of the Ponto Implant System Using Minimally Invasive Ponto Surgery (in Adult Patients)
A clinical trial, sponsored by Oticon Medical.
- Completed
- Registry status
- 64
- Enrollment target
NCT04279236: Completed study, sponsored by Oticon Medical.
NCT04279236 is a clinical trial that has completed, run by Oticon Medical. The registered enrollment target is 64 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04279236 has completed, sponsored by Oticon Medical.
- COMPLETED
- Registry status
- 64 participants
- Enrollment target
Study Summary
This prospective, multi-center study funded by Oticon Medical AB will be conducted at six clinical sites in North America. Patients with a hearing loss and that are already planned for treatment with a percutaneous (through the skin) bone-anchored hearing system (BAHS) will be included in the study. The total number of participants included in the study will be 64. The purpose of this study is to investigate the rate of successful BAHS use after implantation of the Ponto Implant system using the surgical technique Minimally Invasive Ponto Surgery (MIPS).
Primary Outcome
The variables assessed to determine reliable anchorage in the study are implant survival and stability, skin reactions, skin over-growth and pain preventing use of the sound processor. For a positive outcome of the primary endpoint (reliable anchorage), the implant should be in place and stable. without any adverse skin reactions or skin over-growth and pain preventing usage of the sound processor.
Interventions
- OTHER Abbreviated Profile Hearing Aid Benefit (APHAB)
- OTHER Glasgow Benefit Inventory (GBI)
- OTHER Additional follow-up visit
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 64 participants |
| Start Date | 2020-06-15 |
| Est. Completion | 2024-12-10 |
What the finished NCT04279236 record still lists
NCT04279236 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 64 participants, a relatively small participant target.
The record links to 0 conditions, and to 3 interventions - of which Abbreviated Profile Hearing Aid Benefit (APHAB) is the first listed.
NCT04279236 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04279236 about?
NCT04279236 is a clinical study titled "Multi-Center Study on Performance of the Ponto Implant System Using Minimally Invasive Ponto Surgery (in Adult Patients)". This prospective, multi-center study funded by Oticon Medical AB will be conducted at six clinical sites in North America. Patients with a hearing loss and that are already planned for treatment with a percutaneous (through the skin) bone-anchored hearing system (BAHS) will be included in the study....
What is the current status of trial NCT04279236?
This trial is currently completed. The enrollment target is 64 participants. The study started on 2020-06-15. Estimated completion is 2024-12-10.
What interventions are being tested in trial NCT04279236?
The interventions under investigation include: Abbreviated Profile Hearing Aid Benefit (APHAB) (OTHER), Glasgow Benefit Inventory (GBI) (OTHER), Additional follow-up visit (OTHER).
Who is sponsoring clinical trial NCT04279236?
This trial is sponsored by Oticon Medical, which has 7 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT01853631 · 64 participants · Phase 1
Activated T-Cells Expressing 2nd or 3rd Generation CD19-Specific CAR, Advanced B-Cell NHL, ALL, and CLL (SAGAN)
- NCT03739502 · 64 participants · Phase 2
A Randomized Phase II Study of Hyperbaric Oxygen in Improving Engraftment in Umbilical Cord Blood Stem Cell Transplant
- NCT03739814 · 64 participants · Phase 2
Inotuzumab Ozogamicin and Blinatumomab With or Without Ponatinib in Treating Patients With Newly Diagnosed, Recurrent, or Refractory CD22-Positive B-Lineage Acute Lymphoblastic Leukemia
- NCT03866408 · 64 participants · Early Phase 1
Insulin Regulation of Lipolysis and Lipolysis Proteins
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI