Clinical trials: sponsored by 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
Osteoarthritis, Knee, Arthritis, Rheumatoid
Evaluation of Medium Cross-linked Polyethylene With and Without Vitamin E for Total Knee Arthroplasty
Prospective, randomized, single-blind, multinational, long-term study for the evaluation of the clinical outcome, oxidation profile and wear analysis of medium cross-linked Polyethylene with and without Vitamin E for total knee…
- Conditions
- Osteoarthritis, Knee, Arthritis, Rheumatoid, Intra-Articular Fractures, Joint Instability
- Trial name
- VIKEP (NCT04618016)
- Testing
- UHMWPE with Vitamin E, UHMWPE without Vitamin E
- Where
- 8 sites in France, Germany
- Volunteers
- 605 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
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
Osteoarthritis, Hip, Arthritis
Longterm-Evaluation of Vitelene® Against Standard
The purpose of this randomised prospective multicenter longterm study is to evaluate the survival rate of the implant, wear and periprosthetic osteolysis of highly cross-linked polyethylene with and without addition of Vitamin E…
- Trial name
- VITAS (NCT01713062)
- Testing
- Vitelene, XLPE
- Where
- 6 sites in Germany
- Volunteers
- 400 people
- Sponsor
- Aesculap AG
Esophageal Cancer, Esophagus Cancer
Endoluminal Vacuum Therapy to Prevent Anastomotic Leakage After Esophagectomy Due to Esophageal Cancer
A prospective, multi-centre, exploratory and observational one-arm study to evaluate preventive Endoluminal Vacuum Therapy(pEVT) to prevent anastomotic leakage after esophagectomy due to esophageal cancer.
- Conditions
- Esophageal Cancer, Esophagus Cancer, Anastomotic Leak
- Trial name
- ESPY (NCT06097078)
- Testing
- Eso-SPONGE®
- Where
- Spain
- Volunteers
- 44 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
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
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
Disk Herniated Lumbar, Disc Disease Degenerative
Clinical Outcome and Fusion Rate of 3D Printed Interbody Fusion Cages and Titanium Coated PEEK Cages
Prospective, Randomized, Single-Blind Study for the Evaluation of the Clinical Outcome and the Fusion Rate of 3D Printed Interbody Fusion Cages and Titanium Coated PEEK Cages in Transforaminal Lumbar Interbody Fusion
- Conditions
- Disk Herniated Lumbar, Disc Disease Degenerative, Spondylolisthesis
- Trial name
- PRINTLIF (NCT05237908)
- Testing
- Transforaminal Lumbar Interbody Fusion
- Where
- Germany
- Volunteers
- 78 people
- Sponsor
- Aesculap AG
Adiposity
Study on the Performance of Symmcora® Mid-term Suture Versus Novosyn® Suture in Patients Undergoing Robotic Assisted Gastric Bypass Surgery
The study is designed as a prospective, mono-centric, randomized, patient blinded comparison of unidirectional barbed suture (Symmcora® mid term, UBS) vs. a conventional suture (Novosyn®, CS).
- Trial name
- BARGASTRO (NCT05433688)
- Testing
- Robotic assisted gastric bypass surgery
- Where
- Germany
- Volunteers
- 150 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
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
Osteolysis, Arthroplasty Complications
Plasmafit® Revision Structan® Hip Endoprosthesis Cup
The aim of this observational study is to collect clinical and radiological results of the new Plasmafit® Revision Structan® Hip Endoprosthesis Cup in a standard patient population and when used in routine clinical practice.
- Conditions
- Osteolysis, Arthroplasty Complications, Instability of Prosthetic Joint, Degenerative Osteoarthritis
- Trial name
- NCT04255966
- Testing
- Plasmafit® Revision Structan®
- Where
- 4 sites in Germany
- Volunteers
- 60 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
Contusions, Incision
Dermal Wound Closure Using Silkam®
Assessment of performance of Silkam® suture material for skin closure. A prospective, single center, single arm, observational study in daily practice.
- Conditions
- Contusions, Incision, Laceration
- Trial name
- DERMASILK (NCT05225714)
- Where
- Spain
- Volunteers
- 161 people
- Sponsor
- Aesculap AG