Investigator-Sponsored Research Program

Research areas

Each Boston Scientific division reviews research requests for a variety of topics pertaining to Boston Scientific products and associated disease states. Submissions should not be limited to the topics of interest included below. All investigator submissions focused around expanding clinical and scientific knowledge and improving understanding of Boston Scientific products will be considered.

We are currently looking for research in the following areas:

Interventional Cardiology/Structural Heart Topics of Interest

TAVR: Acurate™ Aortic Valve System

• Efficacy in complex cases, unique aortic anatomies and subpopulations
• Embolic protection
• Health economics analysis
   

WATCHMAN™ Appendage Closure Device

• Imaging
• Health economics data
• Blood thinner comparative data
• Subgroup analysis
   

Complex PCI

• FFR, iFR, DFR usage
• Health economics and efficiency analysis
   

Stents and Balloons

• Agent and Synergy applications and sub-population data
   

Cardiac Rhythm Management, Diagnostics and Electrophysiology

Subcutaneous ICD:

• Quantification of S-ICD device-related complication severity
• Outcomes after S-ICD device changeout after normal battery depletion
• Evidence-based practices at changeout (e.g., sub-optimal device placement)
• Impact of shared decision making on defibrillator implantation rates

Electrophysiology- Cardiac Mapping and Ablation:

• Prospective evaluation to drive regional adoption or impact on clinical practice,
  patient experience and AF burden

Pulsed Field Ablation:

-Procedural best practices and workflow efficiencies with pulsed field ablation technologies
-Characterization and evaluation of pulsed field ablation in diverse patient populations

Cryoablation:

- Procedural  best practices, workflow, lesion characterization of a variable sized cryoballoon
- Long-term safety and outcomes of a variable sized cryoballoon

Radiofrequency Ablation/Rhythmia:

-Procedural best practices for efficiency and outcomes with RF ablation
-Procedural best practices for efficiency and outcomes related to Rhythmia system features

Diagnostic Devices:

• Outcomes specific to economics and clinical events for arrhythmia diagnostics
  
• Different patient populations that may benefit from arrhythmia monitoring
  
• Impact of AECG data management solutions on workflow & clinic burden PVC burden use and clinical benefit

Heart Failure Diagnostics on CIED Devices:

• Clinical and economic outcomes associated with HeartLogic™ patient monitoring with treatment and alert response protocols
  
• Workflow and data management: logistics of HeartLogic™ integration into clinic workflow and relationship to efficiency and outcomes
  
• HeartLogic™ utility for EP care pathways, e.g. relationship of HeartLogic™ with arrhythmias, monitoring or predicting response to treatments/device therapy, and potential to guide EP interventions

*The Investigator/Sponsor is responsible for complying with the laws and regulations applicable to the proposed research and will be required to provide proof of such compliance to BSC.

Urology Topics of Interest

Urolithiasis

• Treatment outcomes in upper tract urinary stone disease
   

Benign Prostatic Hyperplasia (BPH)

Rezūm™ Water Vapor Therapy (Rezūm)

• Patient Experience
  • Optimizing patient experience without compromising efficacy
• Effectiveness
  • Treatment durability
  • Volume reduction
  • PSA reduction/control
• Sexual Function Preservation
• Disease Progression
  • Comparative impact on BPH disease progression (compared to medications, MITs, and invasive surgical options)
• Health Economic & Cost-savings
• Economic impact compared to other BPH treatments

GreenLight XPS^TM Laser Therapy System (GreenLight)

• Patient experience compared to other BPH treatment types
  • Safety, recovery, and durability of outcomes
  • Day case procedures and increased OR efficiency
• Treatment techniques
  • Impact of technique on patient outcomes
  • Optimization of treatment plans
• Patient Selection
  • Relevant comorbidities and increased risk of bleeding
  • Core considerations for PVP as primary treatment (patient phenotype)
  • PVP as a secondary treatment (following prior treatment failures) 

Oncology Hydrogels – Prostate Cancer

• SpaceOAR™ and SpaceOAR Vue™ Hydrogels for GU Toxicity, GI & GU QOL
• Spacing in moderate and extreme hypofractionation, dose escalation and lesion boost
• Impact of CT visibility on contouring, planning, visualization and adaptive therapy
• Spacing in high-risk patients and extracapsular extension (non-posterior)
• Comparative studies on SpaceOAR Vue advantages relative to other rectal spacers

Female Stress Urinary Incontinence

• The case for minislings as standard of care therapy for stress urinary incontinence
  • Patient experience
  • Economics
• A systematic review and meta-analysis of the safety and efficacy of urinary slings for treating female stress urinary incontinence
• Incidence of complications following sling surgery in high risk women (obesity, medical comorbidities, concomitant hysterectomy etc.)
• Learning curve for Solyx™ Single-Incision Sling System
  

Pelvic Floor Reconstruction

• Use of Capio™ SLIM Suture Capturing Device in native tissue repair for prolapse
• Safety and efficacy of Y- mesh implanted by transabdominal route
  

Male Stress Urinary Incontinence

• AMS 800™ Artificial Urinary Sphincter (AUS) / AdVance™ XP Male Sling System (AdVance XP) vs comparative device studies or succession of prior procedures
  • Patient and/or Caregiver satisfaction and experience
  • Performance & treatment outcomes
• AUS / AdVance XP outcomes on sub-patient populations 
  • Obese, elderly, trauma, neurogenic (i.e. spina bifida)
  • Post BPH procedures: TURP, brachytherapy, etc.
  • Sub-sequent radiation treatment post-device implant
• Atrophy & Erosion studies
  • Female AUS studies
  • Causes for revision, outcomes, best practices
  • Outcomes in conjunction with prolapse repair
  • Patient selection: sling/mesh vs AUS
• Continence and ED
  • Impact of AUS / AdVance XP on sexual function/satisfaction
  • Outcomes with AdVance XP or AUS and Inflatable Penile Prothesis (IPP) combination
• Economics of Incontinence
  • Coping costs (i.e. pads/laundry/pills)
  • Economic impact on society
  • Patient productivity
  • Mental health
• Benefit of diagnosing Incontinence
  • Cardiovascular
  • Diabetes
  • Obesity

Male Erectile Dysfunction (ED)

• Corporal measurements, measurement technique, and resulting cylinder size
• Cylinder sizing methodology/technique
• Satisfaction associated with specific cylinder sizes
• Same sex partner and patient satisfaction
• Safety and performance (erectile function satisfaction) outcomes associated with anal penetration utilizing a penile prosthesis
• Tactra™ Malleable Penile Prosthesis (Tactra) / Spectra™ Concealable Penile Prosthesis (Spectra) AMS 700™ Inflatable Penile Prosthesis (AMS 700)
• AMS 700, post-Tactra/Spectra – satisfaction, complications
• Reservoir fill volumes and satisfaction
• Reservoir model, fill volumes and cylinder size. 
• Penile prosthesis, post-Rezūm therapy
• Repetitive high impact activities (biking, horseback riding and scuba diving), post-penile prosthesis: outcomes.

Neuromodulation Topics of Interest

• Spinal Cord Stimulation
  • Treatment of chronic, intractable pain of the back and legs using the Spectra WaveWriter™ SCS System
    • Of particular interest:
      • Efficacy of combination therapy
      • Programming optimization
      • Contour™ field shaping algorithm vs other field shapes
      • Anatomical vs paresthesia-based neural targeting
• Deep Brain Stimulation
  • Treatment of Parkinson’s Disease and other movement disorders using Vercise™ Deep Brain Stimulation System
    • Of particular interest:
      • Freezing of gait
      • Replacement of other DBS systems with Vercise DBS System
      • Use of multiple frequencies on one lead
      • Use of current fractionalization to maximize overlap with desired structures and minimize stimulation of non-target tissue
      • Novel targets for Parkinson’s Disease, Dystonia, Tremor (may require IDE)