Eligibility of Investigator-Sponsored Research Applications
AMS® support is typically provided in the manner of funding and/or donated devices depending on the type of research. Clinical research involving AMS devices or relating to the disease states listed below, will be considered for funding.
To submit an Investigator-Sponsored Research request, please verify that you meet the eligibility requirements listed below. You must meet these eligibility requirements to be considered for AMS support.
Investigator-Sponsored Research requests must focus on disease states and treatment options related to:
- Prostate Health
- Colorectal Health
- Laser Therapies
- Investigator-Sponsored Research requests will align with AMS’s top evidence priorities. To view the AMS areas of interest, see below.
- Investigators must be qualified by education and experience to conduct the proposed research.
- The protocol and research must conform to all applicable state, federal, national and local laws, regulations, codes of ethics, and other guidelines.
Areas of Interest
AMS evaluates Investigator-Sponsored Research applications against its long-term clinical evidence strategy and needs in the medical community. Funding is prioritized based on alignment with the evidence strategy and the scientific soundness of the study design. Although studies with expected completion and publication dates within one to two years from approval are generally preferred, studies with long-term follow-up are still considered, as are novel ideas or new product concepts.
While all investigator-sponsored research requests will be evaluated and considered, the areas of interest by therapy indicate the company’s evidence priorities. The areas of interest outlined in the following sections will be updated at minimum, annually.
In general, the following research design elements often increase the scientific value of the study:
- Long-term evaluations of efficacy, safety, and economics
- Patient outcomes measured via validated quality of life questionnaires
- Prospective research design
- Historic or active control(s)
In addition to clinical studies for AMS products, AMS is interested in:
- Observational studies, such as epidemiologic studies and certain outcomes research studies where the primary focus is the scientific understanding of disease or of outcomes associated with alternative therapies
- Other types of independent research on disease states, including novel diagnostic screening tools and surveys
Women’s Health Therapies
For the AMS products: MiniArc Precise™ Sling System, Elevate® Anterior & Apical Repair System, or Elevate® Apical & Posterior Repair System, long-term evaluations of efficacy and/or complications are continually of interest.
For the AMS products: MiniArc® Single-Incision Sling System, MiniArc Precise™ Sling System, Elevate® Anterior & Apical Repair System, or Elevate® Apical & Posterior Repair System, the following research studies are of interest.
- Prospective data on return to activity after surgical treatment
- Retrospective or prospective economic data on provider and patient treatment costs
- Prospective efficacy in specific patient populations (examples include but are not limited to weight or age comparisons in any products, ISD vs. hypermobility in MiniArc, and uterine preservation in Elevate Anterior)
Men’s Health Therapies
Clinical studies involving American Medical Systems products are of interest. Men’s Health products include: AMS 700® 3-piece Inflatable Penile Implant, AMS Ambicor® 2-piece Inflatable Penile Implant, Spectra® Non-Inflatable Penile Implant, AMS 800® Urinary Control System, and AdVance® Male Sling System.
Benign Prostate Hyperplasia Therapies
The BPH division is currently focused on Endourology solutions for kidney stones, BPH, and prostate and bladder cancers. We are interested in performing research on our wide variety of AMS products including the StoneLight® holmium laser, the Sureflex end-firing laser fibers, and the entire line of 532nm lasers, including: GreenLight™, GreenLight HPS®, GreenLight XPS® and Aura XP, as well as the wide variety of side-firing and end-firing laser fibers that work with these lasers.
We do strongly encourage all research including those ideas not involving our products to consider applying. We are looking for research involving innovative ideas for treating stones and prostate cancer as well as outcomes evaluation, both clinical and economic, of BPH surgical options as they compare to the GreenLight family of products.
All studies involving animal subjects will be considered according to funding available and interest by the therapy area’s clinical or research and development team.