Clinical trials: sponsored by Aesculap AG
Episiotomy Wound
Novosyn® Quick in Patients Undergoing Episiotomy Closure
Retrospective, monocentric clinical study on the clinical performance of Novosyn® Quick in patients undergoing episiotomy closure.
- Trial name
- RETRO-EPINOQ (NCT05233527)
- Testing
- Episiotomy Closure
- Where
- Spain
- Volunteers
- 229 people
- Sponsor
- Aesculap AG
Cervical Spine Disease, Pain, Postoperative
Clinical Study on the Safety and Efficacy of the Minimally Invasive Ennovate® Method for Pedicle Screw Placement
The study's main purpose is the collection of clinical data on the patients benefit and safety of pedicle screw placement through an innovative minimally invasive surgical approach compared to the state of the art open surgical…
- Trial name
- MISPEC (NCT06960018)
- Testing
- Ennovate® Cervical, open surgical technique, Ennovate® Cervical, minimal invasive surgical technique
- Where
- 3 sites in Germany
- Volunteers
- 76 people
- Sponsor
- Aesculap AG
Degenerative Osteoarthritis, Rheumatic Arthritis
CoreHip - Post Market Clinical Follow-Up Study
The study is designed as a prospective, non-interventional multicentre cohort study. The product under Investigation will be used in Routine clinical practice and according to the authorized Instructions for Use (IfU).
- Conditions
- Degenerative Osteoarthritis, Rheumatic Arthritis, Fractures, Hip, Necrosis, Femur Head
- Trial name
- NCT03685110
- Testing
- CoreHip Total Hip Arthroplasty
- Where
- 6 sites in Germany, Switzerland
- Volunteers
- 248 people
- Sponsor
- Aesculap AG
Osteoarthritis, Knee, Joint Diseases
Comparative Study of Navigation-assisted OrthoPilot® Elite and Robotic-assisted MAKO® Total Knee Arthroplasty
Randomized, controlled, single center observational study to compare the safety and performance of navigation-assisted OrthoPilot Elite and robotic-assisted MAKO total knee arthroplasty (TKA).
- Conditions
- Osteoarthritis, Knee, Joint Diseases, Rheumatoid Arthritis of Knee, Posttraumatic Arthropathy
- Trial name
- ORMAK (NCT05980442)
- Testing
- Navigated total knee arthroplasty, Robot assisted total knee arthroplasty
- Where
- Germany
- Volunteers
- 140 people
- Sponsor
- Aesculap AG
Meningioma, Tumor, Brain
MiDura-Study (Neuro-Patch in Duraplasty)
The aim of this study is to collect systematically and proactively data regarding the performance of Neuro-Patch, like complications and handling, under daily clinical practice when used as intended by the manufacturer
- Conditions
- Meningioma, Tumor, Brain, Chiari Malformation, Vascular Malformation
- Trial name
- MiDura (NCT04189172)
- Where
- 4 sites in France, Germany
- Volunteers
- 328 people
- Sponsor
- Aesculap AG
Surgical Site Infection
Novosyn® CHD vs Polyglactin 910 Suture to Close Wounds After Emergency or Elective Laparotomy or Laparoscopic Surgery
The aim of the study is to elucidate, if the colonization of bacteria is lower on the Novosyn® CHD suture compared to uncoated Polyglactin 910 suture, which will be assessed by the incidence of surgical site infections (SSI: A1…
- Trial name
- POLYNOVO-CHD (NCT05966961)
- Testing
- Novosyn® in emergency or elective laparotomy or laparoscopic surgery, Polyglactin 910 in emergency or elective laparotomy or laparoscopic surgery
- Where
- 4 sites in Italy, Spain
- Volunteers
- 2,998 people
- Sponsor
- Aesculap AG
Hip Arthritis
Post Market Clinical Follow-Up Study of Excia T® Hip Prosthesis
Clinical and radiological 10 year results of Excia T® Hip Stem
- Trial name
- NCT02188095
- Where
- 2 sites in Germany
- Volunteers
- 100 people
- Sponsor
- Aesculap AG
Degenerative Osteoarthritis, Rheumatoid Arthritis
Evaluation of the PHENO4U Data Platform in Patients Undergoing Total Knee Arthroplasty
Prospective, multinational pilot study for evaluation of the Pheno4U data platform in Total Knee Arthroplasty (TKA) patients
- Conditions
- Degenerative Osteoarthritis, Rheumatoid Arthritis, Posttraumatic Arthropathy, Chronic Instability of Knee
- Trial name
- Pheno4U Pilot (NCT05302934)
- Testing
- Pheno4U
- Where
- 4 sites in Germany, United Kingdom
- Volunteers
- 600 people
- Sponsor
- Aesculap AG
Coxarthrosis; Primary, Coxarthrosis; Post-Traumatic
Cemented TrendHip® - Multicenter PMCF Study on Total Indications
This Post Market Clinical Follow-Up (PMCF) study to evaluate the performance and safety of the cemented TrendHip® stem in a prospective follow-up study with patients who underwent a hip arthroplasty with the investigational…
- Conditions
- Coxarthrosis; Primary, Coxarthrosis; Post-Traumatic, Necrosis, Femur Head, Rheumatoid Arthritis
- Trial name
- TRESTI (NCT04943328)
- Testing
- Total Hip Arthroplasty
- Where
- 4 sites in Germany
- Volunteers
- 119 people
- Sponsor
- Aesculap AG
Peri-Prosthetic Joint Infection
IP-coated Revision Hip Implants
The primary aim of the clinical investigation is to demonstrate the efficacy of a silver-based antimicrobial coating on hip implants in the reduction of periprosthetic infections in revision hip arthroplasty due to periprosthetic…
- Trial name
- HIPrevision (NCT06737809)
- Testing
- IP Plasmafit® Revision cup (and stem) system
- Where
- 2 sites in Germany, Poland
- Volunteers
- 268 people
- Sponsor
- Aesculap AG
Prostate Cancer
Symmcora® Long-term Bidirectional Barbed Suture for Anastomosis in Patients Undergoing Robot Assisted Radical Prostatectomy
The aim of this observational study is to show the superiority of the bidirectional barbed suture (Symmcora® Longterm) in terms of time to perform the vesicourethral anastomosis after robot assisted radical prostatectomy compared…
- Trial name
- BARVANA LONG (NCT06055946)
- Testing
- robotic assisted radical prostatectomy
- Where
- 2 sites in Spain
- Volunteers
- 70 people
- Sponsor
- Aesculap AG
Femoral Artery Stenosis, Iliac Artery Stenosis
Retrospective Study of the Uni-Graft® K DV Patch in the Clinical Routine
Uni-Graft® K DV Patch is marketed in Europe since 1999 for reconstructive interventions of the deep femoral, femoral and iliac artery and was also indicated for carotid interventions until 01/2020.
- Conditions
- Femoral Artery Stenosis, Iliac Artery Stenosis, Carotid Artery Stenosis
- Trial name
- RESTUGPA (NCT05117515)
- Testing
- Vascular reconstruction
- Where
- Germany
- Volunteers
- 200 people
- Sponsor
- Aesculap AG
Coxarthrosis; Primary
Ceramic Modular Dual Mobility in Primary Total Hip Arthroplasty (THA)
A randomized controlled trial comparing modular dual mobility inserts with ceramic multilayer coating versus standard polyethylene inserts for primary THA in a cementless acetabular cup
- Trial name
- CeMoD-prime (NCT05547984)
- Testing
- Dual Mobility Cup, Standard Acetabular component
- Where
- Czechia
- Volunteers
- 100 people
- Sponsor
- Aesculap AG
Osteoarthritis, Knee, Joint Diseases
Study to Evaluate the Performance of Navigated TKA With OrthoPilot® pheno4u TKA Level 1
The purpose of this PMCF study is to demonstrate the accuracy of navigation using the new pheno4uTKA Level 1 software for OrthoPilot Elite® and to evaluate its safety and performance.
- Conditions
- Osteoarthritis, Knee, Joint Diseases, Rheumatoid Arthritis of Knee, Posttraumatic Arthropathy
- Trial name
- TKA4U (NCT06955481)
- Testing
- Navigated Total Knee Arthroplasty
- Where
- 4 sites in Czechia, Germany
- Volunteers
- 120 people
- Sponsor
- Aesculap AG
Total Hip Arthroplasty
Post Market Clinical Follow-Up of Plasmafit® Cup
Twelve months follow-up of implant survival and clinical and radiological follow-up of Plasmafit® Cup.
- Trial name
- NCT02019849
- Testing
- Plasmafit® Total Hip Arthroplasty
- Where
- 2 sites in Germany
- Volunteers
- 100 people
- Sponsor
- Aesculap AG
Sternum Closure
STEELEX® Sternum Set + BONE WAX® + STEELEX® Electrode Set in Patients Undergoing Cardiac Surgery
The aim of the study is to assess the effectiveness and performance of using STEELEX® Sternum Set, BONE WAX® and STEELEX® Electrode Set in patients undergoing cardiac surgery.
- Trial name
- STEADY (NCT06065800)
- Testing
- STEELEX® Sternum Set
- Where
- Spain
- Volunteers
- 150 people
- Sponsor
- Aesculap AG
Injury of Abdominal Wall
Effect of Stitch Technique on the Occurrence of Incisional Hernia After Abdominal Wall Closure
The major long term complication of abdominal wall closure after a median laparotomy is the development of an incisional hernia.
- Trial name
- ESTOIH (NCT01965249)
- Testing
- Long stitch, Short Stitch
- Where
- 9 sites in Austria, Germany
- Volunteers
- 425 people
- Sponsor
- Aesculap AG
Chronic Low-back Pain, Degenerative Disc Disease
Postmarket Clinical Follow-Up Study on Arcadius XP L® Interbody Fusion Device
The purpose of this study is to collect clinical and radiological mid-term (min. 1 year) data on the ArcadiusXP L® lumbar stand-alone cage in a post-market clinical follow-up study (PMCF) limited to 60 patients.
- Conditions
- Chronic Low-back Pain, Degenerative Disc Disease, Spondylolysis Lumbar, Postdiscectomy Syndrome
- Trial name
- ARREST (NCT05944081)
- Testing
- ArcadiusXP L® Interbody Fusion System
- Where
- 3 sites in Germany
- Sponsor
- Aesculap AG
Inguinal Hernia
Clinical Performance of HISTOACRYL® LAPFIX - CANNULA for Laparoscopic Inguinal Hernia Repair
The goal of this retrospective study is to identify the incidence of hernia recurrence following the application of Histoacryl® Lapfix - Cannula for laparoscopic mesh fixation in patients undergoing hernia repair surgery.
- Trial name
- HISTOLAP (NCT06298500)
- Testing
- hernia repair surgery
- Where
- Spain
- Volunteers
- 443 people
- Sponsor
- Aesculap AG
Knee Osteoarthritis, Bone; Deformity, Congenital
COREV 2.0 PMCF-Study on Manual and Navigated Revision Knee Patients
The Columbus® Revision endoprosthetic system is bearing the CE-mark. This means that within the scope of this observational study the patient will not be subjected to any additional stressful, study-related medical examinations…
- Conditions
- Knee Osteoarthritis, Bone; Deformity, Congenital, Prosthesis Failure, Prosthesis-Related Infections
- Trial name
- COREV (NCT05113303)
- Testing
- Navigated Revision Total Knee Arthroplasty, Manual Revision Total Knee Arthroplasty
- Where
- Spain
- Volunteers
- 100 people
- Sponsor
- Aesculap AG