Clinical trials: Pelvic Injury
Iatrogenic Vessel Injury
Treatment of Patients With Traumatic or Iatrogenic Vessel Injuries
The purpose of this study is to confirm device efficacy and safety of the GORE® VIABAHN® Endoprosthesis (hereafter "VB device") for the treatment of traumatic or iatrogenic vessel injury in thoracic, abdominal, and pelvic…
- Trial name
- NCT05183399
- Testing
- GORE® VIABAHN® Endoprosthesis
- Volunteers
- 30 people
- Sponsor
- W.L.Gore & Associates
Osteoarthritis (OA) of the Hip, Avascular Necrosis of Bone of Hip
MDR Vivacit-E Elevated Study
The main objective of this study is to confirm long-term safety, performance, and clinical benefits of the Vivacit-E Vitamin E HXLPE Elevated Liners when used in primary total hip arthroplasty.
- Conditions
- Osteoarthritis (OA) of the Hip, Avascular Necrosis of Bone of Hip, Protrusio Acetabuli, Traumatic Arthropathy-Hip
- Trial name
- NCT07150221
- Testing
- Vivacit-E Elevated Liners
- Where
- United States
- Volunteers
- 52 people
- Sponsor
- Zimmer Biomet
Surgically Created Bone Defects or Bone Defects/Voids Resulting From Traumatic Injury
OSsIRIS Study - A Post-market Clinical Follow-up Investigation.
This is a prospective, observational, non-randomized, multicenter, international post-market clinical follow-up investigation aiming to confirm the performance and safety of the bone substitute b.Bone after implantation in…
- Trial name
- OSsIRIS (NCT06156904)
- Testing
- Bone grafting for the treatment of surgically created bone defects or bone defects/voids resulting from traumatic injury to promote healing in the pelvis, upper and lower extremities.
- Where
- 4 sites in Germany, United Kingdom
- Volunteers
- 135 people
- Sponsor
- GreenBone Ortho S.p.A.
Radiotherapy Side Effect, Pelvic Cancer
AI as an Aid for Weekly Symptom Intake in Radiotherapy
The study investigates the use of artificial intelligence (AI) and large language models (LLMs) to enhance the efficiency and accuracy of weekly treatment consultations (OTVs) in radiotherapy.
- Conditions
- Radiotherapy Side Effect, Pelvic Cancer, Patient
- Trial name
- NCT06525181
- Testing
- Generative Artificial Intelligence, Standard weekly symptom intake
- Where
- Brazil
- Volunteers
- 200 people
- Sponsor
- jaide
Acquired Bleeding Disorder, Trauma
Activated Recombinant Human Factor VII in Pelvic-acetabular Fracture Reconstruction
This trial is conducted in Europe. The aim of this trial is to evaluate the efficacy of activated recombinant human factor VIIgiven in conjunction with standard therapy in patients undergoing major orthopaedic surgery following…
- Trial name
- NCT01601457
- Testing
- activated recombinant human factor VII
- Where
- United Kingdom
- Volunteers
- 48 people
- Sponsor
- Novo Nordisk A/S
Hip Osteoarthritis
OXINIUM◊ DH Total Hip Arthroplasty Pivotal Study
The purpose of this study is to monitor safety of the participants implanted with the OXINIUM◊ DH Hip System up to 10-years post-implantation
- Trial name
- NCT02353377
- Testing
- OXINIUM DH Hip System, BIOLOX◊
- Volunteers
- 413 people
- Sponsor
- Smith & Nephew, Inc.
Osteoarthritis, Tendinitis
Evaluation of Outcomes With Umbilical Cord Allograft for Musculoskeletal Conditions Musculoskeletal Conditions
The aim of the study is to determine the efficacy of an Amniotic Fluid Tissue Product for pain relief and functional improvements for all types of musculoskeletal conditions.
- Conditions
- Osteoarthritis, Tendinitis, Sports Injury, Degenerative Disc Disease
- Trial name
- NCT03390920
- Testing
- Umbilical Allograft
- Where
- United States
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- R3 Stem Cell
Pathologic Fracture
Performance and Safety of the Innofix® Screw (IF25)
The purpose of this clinical investigation is to collect data about the safety and the performances of the InnoFix® screw : Clinical performances (Pain reduction due to the fracture treatment, maintenance of the stabilizaton of…
- Trial name
- IF25 (NCT06800417)
- Testing
- Percutaneous fixation by internal cemented screw (InnoFix®)
- Volunteers
- 34 people
- Sponsor
- Innoprod Medical
Degenerative Sacroiliitis, Sacroiliac Joint Disruption
Sacroiliac Joint Fusion With iFuse Implant System (SIFI)
The purpose of this study is to evaluate the use of the iFuse Implant System to treat degenerative sacroiliitis (arthritis of the SI joint) and sacroiliac disruption (abnormal separation or tearing of the sacroiliac joint).
- Trial name
- SIFI (NCT01640353)
- Where
- 26 sites in United States
- Volunteers
- 194 people
- Sponsor
- SI-BONE, Inc.
Degenerative Sacroiliitis, Sacroiliac Joint Disruption
Investigation of Sacroiliac Fusion Treatment (INSITE)
The purpose of this study is to compare outcomes when patients with degenerative sacroiliitis (arthritis of the SI joint) and or sacroiliac disruption (abnormal separation or tearing of the sacroiliac joint)undergo either SI…
- Trial name
- INSITE (NCT01681004)
- Testing
- iFuse Implant System, Non-surgical management
- Where
- 19 sites in United States
- Volunteers
- 159 people
- Sponsor
- SI-BONE, Inc.
Pelvic Ring Fracture, Acetabular Fracture
Curvafix® Intramedullary System for Fixation of Pelvic and Acetabular Fractures, A Post Market Evaluation
Prospective, single arm, post-market evaluation to evaluate the use and performance of the IM Implant in a post market setting.
- Conditions
- Pelvic Ring Fracture, Acetabular Fracture, Pelvic Fracture, Pelvic Fracture Acetabulum
- Trial name
- NCT05606042
- Testing
- IM Implant
- Where
- 6 sites in United States
- Volunteers
- 53 people
- Sponsor
- CurvaFix, Inc.
Pelvic Floor, Perineal Rupture
Vaginal Tactile Imaging in Assessment of Pelvic Floor Conditions Before the Delivery
The mechanical demands placed on the pelvic floor structures during vaginal delivery often exceed physiological tissue limits, resulting in maternal childbirth trauma, considerable postpartum morbidity, and increased risk of…
- Conditions
- Pelvic Floor, Perineal Rupture, Obstetric Trauma
- Trial name
- NCT03883867
- Where
- 3 sites in United States, Czechia
- Volunteers
- 20 people
- Sponsor
- Advanced Tactile Imaging, Inc.
Bladder Cancer, Prostate Cancer
Medtronic Hugo™ Robotic Assisted Surgery (RAS) System in Urologic Surgery (Expand URO)
This study will evaluate the safety and performance of the Medtronic Hugo™ RAS System when used for urologic RAS procedures.
- Conditions
- Bladder Cancer, Prostate Cancer, Kidney Cancer, Pelvic Tumor
- Trial name
- NCT05696444
- Testing
- RAS Prostatectomy, RAS Cystectomy, RAS Nephrectomy
- Where
- 6 sites in United States
- Volunteers
- 144 people
- Sponsor
- Medtronic - MITG
Fracture; Pelvic, Insufficiency Fractures
Real World Evidence of SI-BONE's iFuse TORQ TNT Advancing Treatment of Pelvic Ring Fractures
The purpose of this study is to evaluate outcomes in patients treated with iFuse TORQ TNT for pelvic fragility fractures.
- Conditions
- Fracture; Pelvic, Insufficiency Fractures, Fragility Fracture, Sacroiliac; Fusion
- Trial name
- REBAR (NCT07530497)
- Testing
- iFuse TORQ TNT Implant System
- Where
- 2 sites in United States
- Volunteers
- 120 people
- Sponsor
- SI-BONE, Inc.
Vaginal Delivery, Pelvic Organ Prolapse
EASE: The Materna Prep Pivotal Study
This study is designed to evaluate the safety and effectiveness of the Materna Prep Device in reducing pelvic muscle injuries during vaginal delivery.
- Trial name
- NCT03973281
- Testing
- Materna Prep Device, Standard of Care (SOC)
- Where
- 22 sites in United States
- Volunteers
- 420 people
- Sponsor
- Materna Medical
Childbirth
A Clinical Phase II Study of the Materna Device to Shorten Delivery Time During Childbirth
This feasibility study is a prospective, non-randomized, single arm study to evaluate safety and prevention of maternal pelvic soft-tissue damage using the Materna Medical Device.
- Trial name
- NCT06698185
- Testing
- Materna Prep Device
- Where
- United States
- Sponsor
- Materna Medical
Degenerative Sacroilitis, Sacroiliac Joint Disruption
LOIS: Long-Term Follow-Up in INSITE/SIFI
The purpose of this study is to evaluate the long term safety and effectiveness of SI joint fusion using the iFuse Implant System in patients with degenerative sacroiliitis (DS) and/or sacroiliac joint disruptions (SD).
- Trial name
- LOIS (NCT02270203)
- Testing
- Pelvic CT at 5 years post-op
- Where
- 12 sites in United States
- Volunteers
- 103 people
- Sponsor
- SI-BONE, Inc.
Fracture;Pelvis, Sacral Fracture
Sacral Fracture Fusion/Fixation for Rapid Rehabilitation
To determine the safety and efficacy of concomitant sacral fracture fixation and sacroiliac (SI) joint fusion vs. non-surgical management for patients with debilitating sacral fragility or insufficiency fractures
- Conditions
- Fracture;Pelvis, Sacral Fracture, Sacroiliac; Fusion, Fragility Fracture
- Trial name
- SAFFRON (NCT05426356)
- Testing
- Surgical Intervention, Non-Surgical Management
- Where
- 7 sites in United States
- Volunteers
- 28 people
- Sponsor
- SI-BONE, Inc.
Pregnancy, Childbirth
Comparison of the Flexibility of the Perineum in Primiparous Women Using the Medical Device Emagina During 90 Days of Their Pregnancy Compared to Those Having a Standard Pregnancy Follow-up
The goal of this clinical investigation is to learn if training with Emagina device can improve flexibility of the perineum during childbirth with the help of a balloon that inflates in the genital area according to a…
- Trial name
- PeriFlex (NCT06542744)
- Testing
- Training with the Emagina device at home until birth, No intervention
- Where
- 15 sites in France
- Volunteers
- 88 people
- Sponsor
- Mumming
Vaginal Delivery, Pelvic Organ Prolapse
Materna Prep Study Phase II
This study is designed to evaluate the safety and effectiveness of the Materna Prep Device in reducing pelvic muscle injuries during vaginal delivery.
- Trial name
- EASE (NCT06126328)
- Testing
- Materna Prep Device
- Where
- 15 sites in United States
- Volunteers
- 214 people
- Sponsor
- Materna Medical