Clinical trials: open to volunteers, sponsored by Aesculap AG
Abdominal Aortic Aneurysm, Morbid Obesity
Pilot Study on the Effectiveness and Safety of OPTILENE® SILVER MESH ELASTIC in Prevention of Surgical Site Infection (SSI) and Incisional Hernia (IH)
The aim of the study is to describe the effectiveness of Optilene® Silver Mesh Elastic on prevention of surgical site infection (SSI) at 6 months follow-up in patients undergoing urgent laparotomy by collecting clinical data on…
- Trial name
- SSIHLVER (NCT06547138)
- Testing
- Prophylactic mesh
- Where
- 5 sites in Spain
- Volunteers
- 110 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
Subdural Hematoma, Subdural Hematoma, Chronic
Study On Histoacryl Used For Embolization Of Middle Meningeal Artery (MMA) In Chronic Subdural Hematoma (CSDH)
The aim of the study is to proof the effectiveness of Histoacryl® on preventing recurrence or progression of subdural hematoma after embolization of the middle meningeal artery.
- Trial name
- HARMONY (NCT07258069)
- Testing
- Histoacryl®
- Where
- 6 sites in Japan
- Volunteers
- 178 people
- Sponsor
- Aesculap AG
Arthroplasty, Arthroplasty Replacement, Knee
oneKNEE - Prospective, Non-interventional, Multicenter PMCF-Study
Safety and Clinical Performance in terms of clinical outcome of oneKNEE® (total knee arthroplasty TKA), evaluated 2 years after implantation.
- Conditions
- Arthroplasty, Arthroplasty Replacement, Knee, Prosthetic Joint Infections of Knee, TKA Outcomes
- Trial name
- oneKNEE (NCT07682909)
- Testing
- oneKNEE®
- Volunteers
- 1,020 people
- Sponsor
- Aesculap AG
Gonarthritis, Degenerative Disease
Clinical Performance and Safety of the Unicompartmental Univation® XF Pro Implant
The study is designed as a prospective, observational, mid-term, multi-center follow-up study. It is planned to include 150 patients from 4 different study centres in Germany.
- Trial name
- UNI_XF_PRO (NCT06657248)
- Testing
- univation® XF Pro
- Where
- 4 sites in Germany
- Volunteers
- 150 people
- Sponsor
- Aesculap AG
Primary Osteoarthritis, Cartilage Degeneration
DEXA Bone Density Analysis of the CoreHip® Prosthesis System
The goal of this interventional post-market follow-up study is to evaluate radiological changes in the diaphyseal bone density (Gruen Zones 3 and 4) within 24 months postoperative in patients treated with CoreHip® primary…
- Conditions
- Primary Osteoarthritis, Cartilage Degeneration, Osteoarthritis, Hip, Inflammatory Arthritis
- Trial name
- CODEX (NCT06632301)
- Testing
- Primary hip replacement with cementless stem
- Where
- Germany
- Volunteers
- 40 people
- Sponsor
- Aesculap AG
Gingivitis, Gingival Diseases
NOVOSYN® Quick Versus MONOSYN® Quick Suture Material in Resective Periodontal Surgery
The aim of this study is to prove that Novosyn Quick and Monosyn Quick are equivalent in early wound healing in adult patients undergoing resective periodontal surgery.
- Conditions
- Gingivitis, Gingival Diseases, Periodontal Diseases
- Trial name
- NOQMOQS (NCT05813236)
- Testing
- Novosyn® in resective periodontal surgery, Monosyn® in resective periodontal surgery
- Where
- Spain
- Volunteers
- 84 people
- Sponsor
- Aesculap AG
Hemorrhage, Gastrointestinal Hemorrhage
HISTOACRYL® Used for Embolization of Thoracoabdominal Artery Bleeding
This observational study will collect information from adult patients in Japan who are treated with Histoacryl® to stop bleeding from arteries in the chest or abdomen, in order to better understand how well the treatment works…
- Conditions
- Hemorrhage, Gastrointestinal Hemorrhage, Hemoptysis, Postpartum Hemorrhage
- Trial name
- HEAL (NCT07753005)
- Testing
- Embolization therapy
- Where
- 11 sites in Japan
- Volunteers
- 176 people
- Sponsor
- Aesculap AG
Spine Fracture, Degenerative Disc Disease
Post-Market Clinical Follow-Up Study on the Safety and Performance of Ennovate® Cervical
Multicenter Post market clinical follow-up Study on the Safety and Performance of Ennovate® Cervical - Prospective, pure data collection of all Ennovate Cervical patients in Total Indications
- Conditions
- Spine Fracture, Degenerative Disc Disease, Spinal Instability, Spinal Tumor
- Trial name
- CERISE (NCT05296889)
- Testing
- posterior stabilization for the cervical spine
- Where
- 4 sites in Germany
- Volunteers
- 200 people
- Sponsor
- Aesculap AG
Bone Regeneration
Performance and Safety of Lyoplant® in Guided Bone Regeneration (GBR) in Oral Surgery
Guided Bone Regeneration (GBR) is a well-established surgical technique that employs barrier membranes to ensure the stability of bone augmentation material while preventing the infiltration of soft tissue, thereby facilitating…
- Trial name
- LyOral (NCT06732167)
- Testing
- GBR Lyoplant, GBR Bio-Gide
- Where
- 2 sites in Spain
- Volunteers
- 68 people
- Sponsor
- Aesculap AG
Anastomotic Leak, Colon Cancer
Leakage Rate of Ileo-COlic Sutured Anastomosis After Right Hemicolectomy
The primary aim of the study is to show that the ileo-colic anastomosis leakage rate until the first 30 days after surgery using MonoPlus® suture material for anastomosis construction after right hemicolectomy is not inferior to…
- Conditions
- Anastomotic Leak, Colon Cancer, Right Hemicolectomy
- Trial name
- LICOSARH (NCT07132970)
- Testing
- Monoplus Suture Material
- Where
- 4 sites in Germany
- Volunteers
- 249 people
- Sponsor
- Aesculap AG
Abnormal Uterine Bleeding, Endometriosis
Performance of SYMMCORA® vs. V-Loc® Suture Material in Patients Undergoing Laparoscopic Total Hysterectomy
The aim of this study is to show the superiority of the new unidirectional barbed suture (SYMMCORA® mid-term, unidirectional) to conventional suture material in terms of time to perform the vaginal cuff closure during gynecologic…
- Conditions
- Abnormal Uterine Bleeding, Endometriosis, Uterine Prolapse, Uterine Cancer
- Trial name
- BARHYSTER (NCT06024109)
- Testing
- Closure of the Vaginal Cuff after Total Hysterectomy
- Where
- 2 sites in Germany, Spain
- Volunteers
- 132 people
- Sponsor
- Aesculap AG
Hyperkyphosis, Hyperlordosis
Post-Market Clinical Follow-Up Study on the Safety and Performance of Ennovate® Complex
Multicenter, multinational Post-Market Clinical Follow-Up (PMCF) study on the safety and performance of Ennovate® Complex - A prospective, pure data collection of all Ennovate® scoliosis patients in selected centers (not…
- Conditions
- Hyperkyphosis, Hyperlordosis, Congenital Scoliosis, Neuromuscular Scoliosis
- Trial name
- COSINE (NCT05281757)
- Testing
- posterior stabilization for the cervical spine
- Where
- 2 sites in Czechia, Malaysia
- Volunteers
- 200 people
- Sponsor
- Aesculap AG
Revision Total Hip Arthroplasty, Periprosthetic Fracture of Hip
Prospective Follow-up of the Prevision Hip Stem With Comparison of Different Implant Variants
The study design is confirmative for non-inferiority of the functional outcome of the implants and is intended to examine the safety and performance of the Prevision hip stem.
- Trial name
- PREMO (NCT06626490)
- Testing
- Prevision Revision hip endoprosthesis stem implantation
- Where
- 2 sites in Germany, United Kingdom
- Volunteers
- 120 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
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
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
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
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