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Clinical assessment of a new adhesive and HME for night-time use in laryngectomized patients: Provox Luna

The objective of this clinical investigation is to evaluate the clinical performance of Provox Luna in comparison to the usual care of the patient.

A multi center, prospective, randomized controlled trial comparing cervical arthroplasty to anterior cervical discectomy and fusion (ACDF) for the treatment of cervical degenerative disc disease.

The primary objective of this investigation is to evaluate the performance of the DISCOVER Artificial CervicalDisc in the treatment of cervical disc disease by measuring the function assessed via Neck Disability Index(NDI) and neurological function…

Clinical assessment of a new speaking valve for hands-free speech in laryngectomized patients: Provox® FreeHands FlexiVoice

The objective of this clinical investigation is to evaluate the short- and long-term clinical feasibility of the Provox FreeHands FlexiVoice, in combination with the currently available attachments, and explore its limitations and advantages.

A MULTI-CENTRE, PROSPECTIVE, POST MARKETING SURVEILLANCE STUDY INVESTIGATING THE PERFORMANCE OF CERVICAL ARTHROPLASTY FOR THE TREATMENT OF CERVICAL DEGENERATIVE DISC DISEASE (DDD)

The primary objective of this investigation is to evaluate the performance of the DISCOVER Artificial Cervical Disc in the treatment of cervical disc disease by measuring the function assessed via Neck Disability Index (NDI) and neurological…

Effectiveness of postoperative radiotherapy in patients with oral or oropharyngeal squamous cell carcinoma and histologically confirmed single ipsilateral lymphnode metastasis (pN1)

To determine the optimal therapy for patients with pT1-2 pN0 oral and oropharyngeal cancer

A multicenter randomized crossover study of a new peristomal adhesive and Heat and Moisture Exchanger (HME) for nighttime pulmonary rehabilitation in laryngectomized patients.

The primary objective of this clinical investigation is to investigate the effect of the Provox Luna system on compliance of HME use. Compliant use is defined as daily use of an HME for at least 20 hours per day 86% (=24/28; each study period is 4…

Low dose cisplatin weekly versus high dose cisplatin every three weeks in primary chemoradiation in sarcopenic head and neck cancer patients.

This study has been transitioned to CTIS with ID 2024-514919-10-00 check the CTIS register for the current data. To investigate if the use of weekly low dose cisplatin increases compliance to the planned chemotherapy scheme in LA-HNSCC patients with…

Microstructured BCP granules as bone graft substitute in maxillary sinus floor augmentation with two-stage implant placement

The primary objective is to determine the efficacy of MagnetOs BCP granules in inducing adequate bone quantity and quality to support endosseous dental implants in the two-staged maxillary sinus floor augmentation procedure. Herein the treatment…

Feasibility study of a mouldable peristomal adhesive for pulmonary and speech rehabilitation after total laryngectomy.

The novel mouldable peristomal adhesive (Provox Life FreeHands Adhesive) can be modelled to the patient*s neck and stoma shape when warmed, and remains its shape when cooled. The hypothesis is that this mouldable peristomal adhesive will improve the…