Clinical trials: Patient-Reported Outcome Measures
Urinary Incontinence
An Evaluation of the PureWick™ Male External Catheter Versus an Established Comparator Overnight in the Home Setting for Incontinence in Adult Males
This post-market study will assess the performance of and user satisfaction with the PureWick™ Male External Catheter in a home setting.
- Trial name
- PUREST-M (NCT07282860)
- Testing
- PureWick System, UltraFlex Self-Adhering Male External Catheter
- Where
- 15 sites in United States
- Volunteers
- 120 people
- Sponsor
- C. R. Bard
Vulvodynia
Validation of Patient Reported Outcome Measures for Use in Vulvodynia
The overall aim of this project is to demonstrate content validity and usability of the modified Vulvar Pain Assessment Questionnaire (mVPAQ), the modified Female Sexual Function Index (mFSFI), and pain on intercourse Numeric…
- Trial name
- NCT03770169
- Where
- 4 sites in United States
- Volunteers
- 20 people
- Sponsor
- Ipsen
Oral Mucositis
A Trial Assessing Chemo Mouthpiece Device With Best Supportive Care for Symptoms of Chemotherapy-Induced Oral Mucositis
This study will compare the use of the Chemo MouthpieceTM device along with best supportive oral care to best supportive oral care alone to rate the effectiveness of Chemo MouthpieceTM in lessening symptoms associated with…
- Trial name
- NCT04595838
- Testing
- Chemo Mouthpiece, Best Supportive Care only
- Where
- 11 sites in United States
- Volunteers
- 176 people
- Sponsor
- Chemo Mouthpiece
Vulvar Atrophy, Vulvovaginal Signs and Symptoms
Retrospective Cohort Study of Symptoms and Quality of Life in Women With Genitourinary Syndrome of Menopause.
The goal of this clinical trial is to retrospectively identify the most prevalent symptoms of genitourinary syndrome of menopause (GSM) among postmenopausal women and to evaluate their impact on quality of life.
- Conditions
- Vulvar Atrophy, Vulvovaginal Signs and Symptoms, Genitourinary Syndrome of Menopause (GSM), Quality of Life
- Trial name
- NCT07737782
- Where
- Spain
- Volunteers
- 100 people
- Sponsor
- Mucosa Innovations, S.L.
Knee Arthroplasty, Patient Engagement
Limited Market Release - MotionSense Clinical Use Evaluation
Prospective evaluation of patient compliance and prescribed home exercise program using MotionSense wearable system during recovery from primary total knee arthroplasty.
- Conditions
- Knee Arthroplasty, Patient Engagement, Patient-Reported Outcome Measures (PROMs)
- Trial name
- FS5 (NCT05091918)
- Testing
- MotionSense
- Where
- 2 sites in United States
- Volunteers
- 101 people
- Sponsor
- Orthosensor, Inc.
Ankle Injuries, Syndesmotic Injuries
Grappler Interference Screw Post-Market Collection of Patient Reported Outcome Measures
Ambispective, multi-surgeon, single site, consecutive case series to determine the safety, performance, and benefits of the Grappler(R) Interference Screw.
- Conditions
- Ankle Injuries, Syndesmotic Injuries, Ankle Inversion Sprain, Deltoid Ankle Sprain
- Trial name
- NCT05190874
- Testing
- Grappler Interference Screw System
- Where
- United States
- Volunteers
- 19 people
- Sponsor
- Paragon 28
Hip Disease
ACE Acetabular Cup Spanish PMCF Study
A total hip replacement is one of the most successful and cost-effective surgical procedures in orthopaedics, involving the replacement of both the hip ball and socket.
- Trial name
- NCT07115732
- Testing
- Total Hip Replacement
- Where
- Spain
- Volunteers
- 120 people
- Sponsor
- JRI Orthopaedics
Hip Disease
ACE Acetabular Cup UK Multi-centre PMCF Study
A total hip replacement is one of the most successful and cost-effective surgical procedures in orthopaedics, and involves replacing both the hip ball and socket.
- Trial name
- NCT04123431
- Testing
- Total Hip Replacement
- Where
- United Kingdom
- Volunteers
- 225 people
- Sponsor
- JRI Orthopaedics
Hypogonadism
A Study to Test a Measure of Symptoms of Older Men With Low Testosterone On and Off Testosterone Replacement Treatment (P05815)
Hypogonadal males, particularly those whose condition manifested later in life, may experience common symptoms associated with their hypogonadism. Questionnaires developed to assess these symptoms need to be tested.
- Trial name
- NCT00254553
- Testing
- Testim 1% (testosterone gel)
- Volunteers
- 150 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Growth Hormone Deficiency in Children
Validation of a Questionnaire That Identifies the Reasons for Non-adherence to Existing Growth Hormone Therapy
The aim of the study is to examine the suitability, the so-called validation, of a questionnaire, with which one can grasp the reasons why injections of growth hormones are omitted by patients ("non-adherence").
- Trial name
- NCT03672617
- Testing
- No treatment given
- Where
- Germany
- Volunteers
- 321 people
- Sponsor
- Novo Nordisk A/S
Hallux Valgus
Validation of Patient Reported Outcome Measures for Use in Hallux Valgus
The purpose of the study is to explore whether the mFFI is fit for purpose in adults with hallux valgus (HV).
- Trial name
- NCT03846687
- Where
- 3 sites in United States
- Volunteers
- 21 people
- Sponsor
- Ipsen
Meniscus Tear
SoftStitch™ for All-Inside Meniscal Repair: Comparative Analysis of Patient Reported Outcome Measures
Acute and traumatic knee meniscus tears are a frequent occurrence. Evidence shows meniscal repair results in more favorable patient reported outcomes and articular cartilage preservation.1 This prospective, multicenter, single…
- Trial name
- NCT05491564
- Testing
- SoftStitch™
- Volunteers
- 50 people
- Sponsor
- Arthrex, Inc.
Breast Cancer
PAS 1ml Magtrace® for Sentinel Lymph Node Biopsy in Breast Cancer Patients
The purpose of this study is to provide prospective evidence in the US population of the frequency of skin discoloration and Sentinel Lymph Node detection rate in patients who have recevied Magtrace for Sentinel Lymph Node Biopsy…
- Trial name
- MAGProm (NCT06610539)
- Where
- 2 sites in United States
- Volunteers
- 184 people
- Sponsor
- Endomagnetics Ltd.
Knee Arthroplasty, Total
Evaluation of Navigation-Assisted TKA Using Mechanical vs. Restricted Kinematic Alignment
The purpose of this study is to evaluate both clinical measures and PROMs in patients undergoing total knee arthroplasty (TKA) using restricted inverse kinematic alignment (iKA) compared to mechanical alignment (MA), both using…
- Trial name
- NCT05516381
- Testing
- Optetrak Logic CR Knee System
- Where
- Spain
- Volunteers
- 148 people, healthy volunteers welcome
- Sponsor
- Exactech
Hip Arthritis, Osteoarthritis, Hip
Observational Study to Collect Safety Data and PROMs on Primary THA
This observational study is designed to collect safety data and PROMs on retrospective primary total hipa arthroplasty surgeries with Trinity cup and Meije Duo cementless hip system
- Conditions
- Hip Arthritis, Osteoarthritis, Hip, Coxitis, Femoral Head Necrosis
- Trial name
- NCT06518993
- Testing
- Total hip arthroplasty with a Trinity cup and a Meije Duo cementless stem
- Where
- France
- Volunteers
- 116 people
- Sponsor
- Corin
Pulmonary Disease, Chronic Obstructive
Research to Evaluate a Possible Relation Between Values Obtained After Processing CT Images, Lung Function Tests and the Experience of the Patient During an Exacerbation in COPD Patients.
In this study the consequences of exacerbations will be visualized by high resolution computed tomography (HRCT) scan at functional residual capacity (FRC) and total lung capacity (TLC) as taken during an episode of exacerbation…
- Trial name
- NCT01684384
- Testing
- Functional Respiratory Imaging
- Where
- 4 sites in Belgium, Italy and 1 more
- Volunteers
- 53 people
- Sponsor
- FLUIDDA nv
Relapsing Multiple Sclerosis
Impact of Disease Modifying Therapies (DMTs) and Associated Support Services in Relapsing Multiple Sclerosis (RMS) Patients
The objective is to establish the impact of current disease modifying therapies (DMTs) and associated support services on Patient Reported Experience Measures and Patient Reported Outcomes in relation to the treatment and…
- Trial name
- NCT01601119
- Testing
- Rebif, Other: Disease modifying therapies (DMT)
- Where
- United Kingdom
- Volunteers
- 545 people
- Sponsor
- Merck KGaA, Darmstadt, Germany
Complete Questionnaires Following TKR Surgery
Development of a New Patient Reported Outcome Measure (PROM) to Assess Patient's Emotional Wellbeing, and Perceptions of Total Knee Replacement Surgery for the Treatment of Knee Arthritis
Development of a new Patient Reported Outcome Measure (PROM) to assess patient's emotional wellbeing, and perceptions of Total Knee Replacement surgery for the treatment of knee arthritis.
- Trial name
- SYNC01- P4 (NCT06585267)
- Where
- United Kingdom
- Volunteers
- 167 people
- Sponsor
- Invibio Ltd
Osteoarthritis, Musculoskeletal Abnormalities
Prospective Evaluation Assessing U2 MB™ Total Knee System
The goal of this study is to evaluate the safety and effectiveness of the United Orthopaedics Mobile Bearing Total Knee System (U2 MB™ Knee) in patients undergoing total knee replacement surgery due to end-stage knee…
- Trial name
- NCT06996158
- Volunteers
- 150 people
- Sponsor
- MSK Doctors & Associates Ltd
Total Knee Replacement
Qualitative Interviews With Healthcare Professionals
PLANNING PHASE- Qualitative interviews with Healthcare Professionals to assist in the development of a new Patient Reported Outcome Measure (PROM) to assess patient's emotional wellbeing, and perceptions of Total Knee Replacement…
- Trial name
- NCT05597046
- Testing
- Interview
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- Invibio Ltd