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Ears, Nose and Throat

Smith+Nephew's Ear, Nose and Throat (ENT) portfolio consists of products for epistaxis, laryngeal and soft palate reduction, septoplasty, turbinate reduction, sinus surgery, tympanostomy, and tonsil and adenoid removal. 

To submit a proposal, navigate to the appropriate study type at the bottom of the page and click the ‘Submit Proposal’ button within.
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Smith+Nephew recognizes the importance of supporting Clinical Activities that lead to a greater understanding of our therapies and their potential applications, improved patient care, and new ideas for further research.​

We accept unsolicited requests for research grants from academic and community-based clinician-scientists who are interested in conducting their own activity.

All investigators who are awarded support must provide Smith+Nephew with ongoing study updates and final deliverables.

We welcome proposals for a variety of clinical activities including Investigator Initiated Studies (IISs), Manuscript and Abstract Preparation activities, Collaborative Clinical Research projects and Real World Evidence activities. Click the tiles at the bottom of this page to learn more about each and proceed with proposal submission.

As the sponsor of the study, the investigator and/or institution assume responsibility for all aspects of the study.

  • Study design and protocol development
  • Institutional and regulatory approvals and reporting
    • IRB/EC approval
    • Registration on ClinicalTrials.gov
    • IND/IDE application submission
    • Serious adverse event reporting to the FDA, IRB, and Smith+Nephew
  • Study conduct in accordance with ICH GCP Guidelines and all applicable local and regulatory requirements
  • Communication of all ongoing study updates (see section below)
  • Reconciliation and closeout reporting (see section below)
  • Clinical study report submission within 90 days of study completion
  • Dissemination of study results in a peer-reviewed publication and/or at a medical meeting within 6 months of study completion

The Investigator needs to complete a study proposal and budget, these will be provided once you have selected the relevant study type below.

It takes approximately 6 to 8 weeks for a proposal to be approved. Once approved the contracting process can take up to 3 months depending on the Institution’s internal contracting process. Investigator should not commence work on a proposal until a fully executed contract is in place. All contracts are with the Institution not the Investigator.

S+N will provide all or partial funding for any IIS that has been approved. S+N would prefer to provide funding to cover the device cost, rather than provide devices, but it can be done if absolutely necessary. Investigators can not be paid directly. All funding is to the institution responsible for and housing the patient data. No exceptions.

The Investigator must notify Smith+Nephew of the following updates for ongoing studies:

  • Amendments to the study protocol
  • Regulatory re-approvals
  • Serious adverse events reports
  • Achievement of study milestones related to milestone payments
  • Subject enrollment progress (e.g., first subject in, last subject in, last subject out, etc.)

A clinical study report (CSR) is required within 90 days of study completion. The CSR should be written in accordance with the ICH Guidance for Structure and Content of Clinical Study Reports. Please refer to our guidance document here. A CSR template is provided for you here.

Submission for publication in a peer-reviewed journal is required within 6 months of study completion. All publications should comply with recognized ethical standards concerning publications and authorship, including the Uniform Requirements for Manuscripts Submitted to Biomedical Journals, established by the International Committee of Medical Journal Editors.

Smith+Nephew at least 30 days in advance of submission for publication. Additionally, we must receive evidence of submission for publication no later than 6 months following completion of the study. For research support that includes funding, the final milestone payment is dependent on submission for publication or presentation of study results.

Benefits to you: Funding support for research interests, Opportunities to collaborate with peers by participating in multi-center S&N sponsored studies and Med Ed opportunities to attend advanced courses/conferences

Benefits to S+N: Evidence to guide strategic direction for the life of the product, Clinical data to support product claims & meet regulatory requirements

Ear

  • Tula Tympanostomy System
  • WEREWOLF◊ COBLATION◊ System◊

Nose

  • CMC Dissolvable Nasal Dressings
  • COBLATION◊ Technology for Turbinate Reduction
  • COBLATION◊ TURBINATOR◊ Turbinate Reduction Wand
  • ENTACT◊ Septal Stapler
  • HALO◊ Wand
  • RAPID RHINO◊ with CMC Technology
  • RAPID RHINO◊ SINU-FOAM◊ Dissolvable Post-Op Dressings
  • RAPID RHINO◊ SINU-KNIT◊ Dissolvable Post-Op Surgical Dressings
  • SERPENT◊ Articulating Instrumentation
  • TURBINATOR

Ear

  • COBLATION◊ Wands for adenotonsillectomy
  • COBLATION◊ Technology for Adenotonsillectomy
  • COBLATION◊ Technology for Airway Management
  • EVAC◊ 70 XTRA and XTRA HP Wands

The following study types may be considered for support:

  • Prospective or Retrospective clinical studies involving Smith+Nephew productss 
  • Non-interventional research, such as epidemiology or outcomes studies, where the focus is on scientific understanding of the disease

We do not provide support for the following: 

  • Proposals that are not aligned with our current areas of interest 
  • Proposals that are conditioned upon past or future prescriptions or purchases of Smith+Nephew products 
  • Requests that create a conflict of interest for Smith+Nephew 


  • Investigator Initiated Studies

    A clinical study designed and initiated by an investigator, whereby S+N provide funding (monetary or medical devices) but do not act as Sponsor.  Any type of study design (qualitative/quantitative) can be an IIS as the design of the study and proposal submitted to S+N for consideration comes directly from the Investigator/HCP. 
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  • Collaborative Research
     

    A clinical activity whereby the design and/or conduct of said activity is done jointly to collaborate on fulfilling the objectives of the activity.  






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  • Manuscript, Abstract, & Publication

    Any type of clinical research whereby an investigator/HCP approaches S+N to ask for assistance (monetary or resource) to analyse and/or write up their existing data (external to S+N) for publication or as a conference proceeding.



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  • Real World Evidence
     

    The collection or extraction of data from routine patient treatment, that is available within the patient medical record (paper or EMR) or at the time treatment/procedure.





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