Clinical trials: sponsored by Aesculap AG
Appendicitis, Cholecystitis
NOVOsyn® for Trocar Incision After Laparoscopic Appendectomy and Cholecystectomy
The aim of this study is to evaluate if the application of a Chlorhexidine coated suture (Novosyn® CHD) will reduce the colonization of bacteria in comparison to an uncoated suture (Novosyn®) used for the closure of trocar wounds…
- Trial name
- NOVOTILAC (NCT04033211)
- Testing
- Novosyn® CHD for fascia and skin closure, Novosyn® for fascia and skin closure
- Where
- 4 sites in Germany, Spain
- Volunteers
- 316 people
- Sponsor
- Aesculap AG
Skull Fractures
PMCF Study on CranioFix®2 System Used for the Fixation of Craniotomized Bone Flaps and Fractures
The CranioFix®2 PMCF study has been set up as an action within the framework of a proactive post-market surveillance system of the manufacturer.
- Trial name
- CRANFLAP (NCT05119595)
- Where
- Germany
- Volunteers
- 25 people
- Sponsor
- Aesculap AG
Craniotomy, Duraplasty
Assessment of the Performance of LYoplant® ONlay for Duraplasty
The aim of this Post Market Clinical Follow-up Study is to collect clinical data on the performance of Lyoplant® Onlay. To assess the performance of the product, various safety and efficacy parameters have been selected.
- Conditions
- Craniotomy, Duraplasty, Spinal Surgery
- Trial name
- LYON (NCT02678156)
- Testing
- Lyoplant Onlay
- Where
- 3 sites in Germany
- Volunteers
- 61 people
- Sponsor
- Aesculap AG
Tumor, Cerebral Ventricle, Tumor, Cerebellar
Post Market Clinical Follow-Up Study on the Performance and Safety of Lyoplant®
Retrospective, single center, single arm PMCF study on the performance and safety of Lyoplant® used for the replacement and extension of connective tissue structures in neurosurgery.
- Conditions
- Tumor, Cerebral Ventricle, Tumor, Cerebellar, Aneurysm Cerebral, Trauma, Brain
- Trial name
- LYOPLACE (NCT05441618)
- Testing
- Lyoplant®
- Where
- Germany
- Volunteers
- 50 people
- Sponsor
- Aesculap AG
Degenerative Instability, Spondylolisthesis
PMCF Study on the Safety and Performance of CESPACE 3D
Prospective, pure data collection of all CeSPACE 3D patients in selected centers (not interventional, multicenter)
- Conditions
- Degenerative Instability, Spondylolisthesis, Post-discectomy Syndrome, Post-traumatic Instabilities
- Trial name
- CATALINA (NCT04477447)
- Where
- 2 sites in Germany
- Volunteers
- 101 people
- Sponsor
- Aesculap AG
Degenerative Instability, Spondylolisthesis
PMCF Study on the Safety and Performance of PROSPACE 3D / PROSPACE 3D OBLIQUE / TSPACE 3D
Prospective, pure data collection of all PROSPACE 3D, PROSPACE 3D Oblique, TSPACE 3D patients in selected centers (not interventional, multicenter
- Conditions
- Degenerative Instability, Spondylolisthesis, Post-discectomy Syndrome, Post-traumatic Instabilities
- Trial name
- PROTONTO (NCT04542577)
- Where
- 2 sites in Germany
- Volunteers
- 208 people
- Sponsor
- Aesculap AG
Abdominal Wall Wound
MonoMax for Abdominal Wall Closure
A great number of different suture techniques and suture materials are in use in order to reconstitute the abdominal wall integrity, but there is no surgical gold standard for abdominal wall closure until today.
- Trial name
- MULTIMAC (NCT01901068)
- Testing
- MonoMax
- Where
- 3 sites in Czechia, Romania
- Volunteers
- 200 people
- Sponsor
- Aesculap AG
Knee Arthritis, Knee Osteoarthritis
In-vivo Wear Behaviour of AS Coated Versus Uncoated Columbus® Total Knee Prosthesis
This clinical study is a Post-Market Clinical Follow-Up (PMCF) measure and is aiming to compare the in-vivo wear behaviour of the Columbus® total knee prosthesis between the standard Cobalt Chromium (CoCr) and the multilayer…
- Conditions
- Knee Arthritis, Knee Osteoarthritis, Primary Osteoarthritis of Knee Nos, Secondary Osteoarthritis of Knee Nos
- Trial name
- COLRAS (NCT05509972)
- Testing
- total knee prosthesis implantation
- Where
- Germany
- Volunteers
- 7 people
- Sponsor
- Aesculap AG
Orthopedic Surgery, Soft Tissue Approximation
MonoPlus® in Orthopedic Surgery
Single-center postmarket clinical follow-up study (PMCF) on the performance and safety of MonoPlus® in patients undergoing orthopedic surgery
- Trial name
- UNITE (NCT05257278)
- Testing
- MonoPlus®
- Where
- Spain
- Volunteers
- 140 people
- Sponsor
- Aesculap AG
Leakage After Esophagectomy, Leakage After Gastrectomy
Eso-Sponge Registry
This international, prospective and multicenter registry was designed to collect clinical evidence for the endoscopic vacuum treatment using Eso-SPONGE® for anastomotic leakage after esophageal resection or iatrogenic or…
- Conditions
- Leakage After Esophagectomy, Leakage After Gastrectomy, Perforation of the Esophagus
- Trial name
- NCT02662777
- Testing
- Eso-SPONGE® vacuum treatment
- Where
- 17 sites in Germany
- Volunteers
- 108 people
- Sponsor
- Aesculap AG
Degenerative Disc Disease, Spondylolisthesis
Quintex® Follow-up After One Year Minimum
Prospective study, not randomised, non-interventional, monocentric, investigating an intended patient cohort of 60 patients already operated on the cervical spine due to degenerative disc disease of the cervical spine down to the…
- Conditions
- Degenerative Disc Disease, Spondylolisthesis, Trauma, Spinal Stenosis
- Trial name
- Quintex (NCT04489394)
- Where
- Germany
- Volunteers
- 60 people
- Sponsor
- Aesculap AG
Laceration, Incision
Optilene® Suture Material for Dermal Sutures
In this non-interventional study, Optilene® suture will be evaluated for skin closure in adult patients.
- Trial name
- OPTIDERMAL (NCT05240248)
- Where
- Spain
- Volunteers
- 172 people
- Sponsor
- Aesculap AG
Tooth, Impacted, Teeth Impact
Performance of Safety of SILKAM® Suture Material in Oral Surgery
Assessment of SILKAM® suture material in mucosal closure in oral surgery (mucosal sutures). A prospective, monocentric, single arm observational study.
- Conditions
- Tooth, Impacted, Teeth Impact, Tooth Impaction, Mucosal Wound
- Trial name
- SILKOS (NCT05296902)
- Testing
- Mucosal Closure
- Where
- Spain
- Volunteers
- 105 people
- Sponsor
- Aesculap AG
Cesarean Section Complications, Cesarean Section; Infection
Performance of Novosyn® in Patients Undergoing Uterus Closure in Cesarean Section
The aim of this study is to collect clinical data on the use of Novosyn® applied for the uterus closure in cesarean section. Diverse parameters have been selected to assess that the safety and effectiveness of Novosyn® is…
- Trial name
- SCOTT (NCT05807633)
- Testing
- Novosyn®
- Where
- Spain
- Volunteers
- 250 people
- Sponsor
- Aesculap AG
Arthroplasty, Replacement, Hip, Arthroplasty, Replacement, Knee
Study Measuring the Effects of Patient Data for Total Hip and Total Knee Arthroplasty Patients Using an APP Based Sensor for Home Exercise Performance Before and After Operation
Multicenter, Prospective, Randomized, Comparative Study Measuring the Effects on Clinical Outcomes, Patient Satisfaction, Costs and Benefits of Combined Pre-, Intra- and Postoperative Patient Data for THA and TKA Patients Using…
- Conditions
- Arthroplasty, Replacement, Hip, Arthroplasty, Replacement, Knee, Clinical Outcome, Patient Satisfaction
- Trial name
- ORTHOPATH (NCT05182320)
- Testing
- OrthoPath, Control
- Where
- 2 sites in Germany
- Sponsor
- Aesculap AG
Eye Diseases
Dafilon® Suture Material in Patients Undergoing Ophthalmic Surgery
This is an observational, retrospective postmarket clinical follow-up study and includes all patients who underwent any ophthalmic surgery using Dafilon® suture in the selected centres between 2018 and 2020, therefore no sample…
- Trial name
- OPHTHADA (NCT05968443)
- Testing
- ophthalmic surgery
- Where
- Malaysia
- Volunteers
- 200 people
- Sponsor
- Aesculap AG
Laceration of Skin, Injury Skin
Assessment of DAFILON® Suture Material for Skin Closure
In this non-interventional study (NIS) a polyamide non-absorbable suture (Dafilon®) will be evaluated for skin closure in adult and pediatric patients.
- Trial name
- SKINDA (NCT04617041)
- Where
- 2 sites in Germany, Spain
- Volunteers
- 115 people
- Sponsor
- Aesculap AG
Degenerative Osteoarthritis, Rheumatoid Arthritis
All Polyethylene Tibia-VEGA Kiel
Obligatory Post-Marketing Clinical Follow-up (PMCF) as part of the post marketing surveillance plan for the product under investigation For this PMCF only CE-marked medical devices will be used within their intended purpose and…
- Conditions
- Degenerative Osteoarthritis, Rheumatoid Arthritis, Post-traumatic; Arthrosis, Other Instability, Knee
- Trial name
- APT-VEGA_KI (NCT02756702)
- Testing
- All-Poly
- Where
- Germany
- Volunteers
- 70 people
- Sponsor
- Aesculap AG
Aortic Valve Stenosis
PremiCron Suture for Cardiac Valve Repair
The study is a voluntary study, initiated by B. Braun to collect clinical data for PremiCron® suture concerning its key indication.
- Trial name
- PremiValve (NCT04096859)
- Where
- 2 sites in Germany, Spain
- Volunteers
- 198 people
- Sponsor
- Aesculap AG
Coronary Artery Disease, Cardiac Valve Insufficiency
Study on the Clinical Performance of Steelex® Sternum Set for Sternal Closure
The study is designed as a retrospective, international, multi-center cohort study to evaluate Steelex® Sternum Set for sternum closure.
- Conditions
- Coronary Artery Disease, Cardiac Valve Insufficiency, Aortic Valve Stenosis
- Trial name
- STERCCAS (NCT05439395)
- Testing
- Sternum Closure after Cardiac Surgery
- Where
- 2 sites in Germany, Spain
- Volunteers
- 229 people
- Sponsor
- Aesculap AG