Brighton East Sussex, United Kingdom

NXT Post-Market Clinical Follow-up

The primary objective of this study is to confirm the safety and performance of NXT urodynamic system for the intended patient populations, medically indicated for urodynamic study.

RESTORE: An RCT to Evaluate the Efficacy of the Revi System

Prospective, multi-center, open label, post market, randomized controlled trial To demonstrate superiority of Revi System therapy vs. non active therapy in the treatment of UUI Treatment Arm: Device: Revi System Subjects will be implanted with a Revi System and activation of therapy will occur ~4 weeks post implantation and continue for the duration of the study. Control Arm: Device: Revi System - Delayed Activation Subjects will be implanted with a Revi System and activation of therapy will be delayed until 4 months post implantation. At this time the Revi System will be activated to begin therapy and will continue for the duration of the study. Randomization in a 1:2 ratio into either the "control group" or the "treatment group" will be performed in blocks of 3 or 6 randomly, across the study population by a central randomization system. Randomization will be stratified by investigational site. The study will consist of the following activities: Visit 1 - Screening - Potential subjects with UUI, who fulfil basic criteria will be informed of the study and will be invited to sign an informed consent form. - Demographic information (age, race, height and weight, leg circumference), medical and surgical history and concomitant medication information will be collected. - Study candidates will be asked to fill out various questionnaires - Patients will be asked to complete a 3- consecutive day voiding diary. - Urine sample will be collected, blood will be drawn and a full physical examination, including a PVR measurement and uroflow (in men), will be performed. Visit 2 - Randomization & Implantation - 5 ± 4 weeks after starting the diary, eligible subjects will be randomized to either the Treatment or Control (delayed activation) arms (2:1) and will undergo unilateral implantation with the BlueWind Revi System - Collection of AE and concomitant medication will be performed Treatment Arm: Visit 3 - Activation - After a recovery period of 4-weeks post implantation, subjects will attend the clinic to undergo physical examination and surgical wound check-up. - Subjects will undergo parameter setting according to the individual patient sensations and will be trained on the use of the system. Visits 4-11 - Treatment optimization and follow up - Follow-up visits will be performed at 1, 2, 3, 6, 9, 12, and 24 months post system activation. - A call visit will be performed at 18-months. - All follow-up visits will require completion of a 3-day voiding diary by the patient before coming to the visit. - During each clinic visit, stimulation parameters and level of treatment will be checked and adjusted as needed. Control Arm: • After a recovery period of 1-month post implantation, subjects will attend the clinic to undergo physical examination and surgical wound check-up. Visit 4 - Activation - After a recovery period of 4-weeks post implantation, subjects will attend the clinic to undergo physical examination and surgical wound check-up. - Subjects will undergo parameter setting according to the individual patient sensations and will be trained on the use of the system. Visits 5-12 - Treatment optimization and follow up - Follow-up visits will be performed at 1, 2, 3, 6, 9, 12, and 24 months post system activation. - A call visit will be performed at 18-months. - All follow-up visits will require completion of a 3-day voiding diary by the patient before coming to the visit. - During each clinic visit, stimulation parameters and level of treatment will be checked and adjusted as needed.

The Role of IL5 in Epithelial Cell Integrity

The investigators hypothesize that anti-IL5 treatment will promote epithelial cell function by inhibition of Type 1 and innate immune mediated inflammation and epithelial-mesenchymal transition resulting from IL5 induction. Aim 1. To test the hypothesis that anti-IL5 therapy results in inhibition of epithelial cell dysfunction including epithelial derived inflammatory responses and barrier dysfunction, the investigators will examine the effect of in vitro anti-IL5 mepolizumab exposure of human primary nasal epithelial cells from chronic rhinosinusitis with nasal polyposis on Type 1, Type 2 and innate immune inflammatory markers, and markers of epithelial cell barrier function. Aim 2. To examine the effect of mepolizumab to broadly modulate the expression of Type 2, Type 1, Type 3, and innate immune inflammatory gene responses in human nasal airway epithelial cells, the investigators will perform high throughput RNA sequencing on IL5 primed differentiated human primary nasal epithelial cells exposed to the presence and absence of mepolizumab in vitro cell culture which are derived from patients with chronic rhinosinusitis with nasal polyposis. These studies will provide an unbiased approach to identification of biomarkers resulting from anti-IL5 treatment.

A Study of LBP-EC01 in the Treatment of Acute Uncomplicated UTI Caused by Drug Resistant E. Coli (ELIMINATE Trial)

This study will consist of two parts. Part 1 - Dose regimen selection: An open-label, 30 patient, 3-arm PK assessment of: Arm 4 (previously 1): LBP-EC01 (approximately 2×10^12 PFU) given by IU administration on D1 and D2 and LBP-EC01 (approximately 1×10^11 PFU) IV given as a 1 milliliter (mL) bolus QD from D1 through D3 concomitantly with oral trimethoprim/sulfamethoxazole (TMP 160mg/SMX 800mg) BID from D1 through D3 (6 doses); Arm 5 (previously 2): LBP-EC01 (approximately 2×10^12 PFU) given by IU administration on D1 and D2 and LBP-EC01 (approximately 1×10^10 PFU) IV given as a 1 mL bolus QD from D1 through D3 concomitantly with oral TMP/SMX BID from D1 through D3 (6 doses); Arm 6 (previously 3): LBP-EC01 (2×10^12 PFU) given by IU administration on D1 and D2 and LBP-EC01 (approximately 1×10^12 PFU) IV given as a 100 mL IV infusion over 2 h on D1 through D3 concomitantly with oral TMP/SMX BID from D1 through D3 (6 doses). Part 2 - Efficacy, Safety, Tolerability and Pharmacokinetics: A blinded, 288 patient, 1:1 randomized evaluation of the Arm 4 dose regimen, selected from Part 1, versus placebo + antibiotic (TMP/SMX -160 mg TMP and 800 mg SMX) given orally BID on Days 1 through 3.

Prospective US Radiofrequency SUI Trial

PURSUIT: Prospective US Radiofrequency SUI Trial (VI-17-06) is a prospective, randomized, sham controlled, double blind study in premenopausal women with stress urinary incontinence. The study will be conducted in 390 subjects, randomized 2:1 with active or sham treatment. Study duration is 12 months post treatment. The primary objective is to evaluate the efficacy of the Viveve treatment, SUI protocol, in improving mild to moderate stress urinary incontinence (SUI), assessed using the 1-hour Pad Weight Test for up to 12 months post-treatment. Secondary endpoints include: - Percent of subjects who are responders in the 1-hour Pad Weight Test at 3- and 6-months post-treatment. - Change from Baseline (CFB) to 3, 6- and 12-months post-treatment in the number of incontinence episodes as assessed by the 3-day bladder voiding diary. - Percent of subjects with no incontinence episodes at 3, 6- and 12-months post-treatment as assessed by the 3-day bladder voiding diary. - CFB to 3, 6, 9- and 12-months post-treatment in the I-QOL, ICIQ-UI-SF, PGI-I and MESA questionnaires. - Percent CFB to 3, 6- and 12-months post-treatment in the 1-hour Pad Weight Test.

MILD® Percutaneous Image-Guided Lumbar Decompression: A Medicare Claims Study

In this study the treatment group will include all patients receiving MILD, and the control group will include all patients receiving IPD for the treatment of LSS during the enrollment period. Reoperation and harms data will be studied for the MILD and IPD procedures for a 24-month follow-up period after the index procedure using Medicare claims data. This study is exempt from IRB oversight (Department of Health and Human Services regulations 45 CFR 46) and does not require prior enrollment nor patient consent. The inclusion of the study's NCT number on MILD Medicare claims is required and results in enrollment.

BlueWind RENOVA iStim™ System for the Treatment of OAB