clinical studies

Link to the study document at the German Clinical Trials Registry

Role of the MLL: Prototype

DRKS-ID of Study:  DRKS00028581

Clinical Partner: Department of Ophthalmology, University Hospital Schleswig-Holstein Campus Kiel, DE

Study 1:

Acquisition of in vivo tumour elastographic data by indentation measurements in the operating theatre.

Study 2:

Proof of concept of a combined ultrasound aspirator and laser instrument for vascular coagulation

Role of the MLL: Prototype and technical monitor

File no. Ethics Committee of the University of Lübeck: 19-319

Clinical Partner: Department of Neurosurgery, University Hospital Schleswig Holstein, Campus Lübeck, DE

Publications:

Hutfilz, A. et al. Pulsed thulium laser blood vessel haemostasis as an alternative to bipolar forceps during neurosurgical tumour resection

Bockelmann N, et al.. Toward intraoperative tissue classification: exploiting signal feedback from an ultrasonic aspirator for brain tissue differentiation.

Sensitivity & specificity of combined OCT compared to conventional fluorescence-based neurosurgical imaging.

Role of the MLL: Prototype and technical monitor

File no. Ethics Committee of the University of Lübeck: 18-204

Clinical Partner: Department of Neurosurgery, University Hospital Schleswig Holstein, Campus Lübeck, DE

Publications:

Strenge, P. et al. The neurosurgical benefit of contactless in vivo optical coherence tomography regarding residual tumor detection: A clinical study

Strenge P. et al. Differentiation of different stages of brain tumor infiltration using optical coherence tomography: Comparison of two systems and histology

Strenge P, et al. Registration of histological brain images onto optical coherence tomography images based on shape information.

Yashin K, et al. OCT-Guided Surgery for Gliomas: Current Concept and Future Perspectives.

Link to the study document at the German Clinical Trials Registry

Role of the MLL: Prototype and sponsor

DRKS-ID of Study:  DRKS00013755

Clinical Partner: Department of Ophthalmology, University Hospital Schleswig-Holstein Campus Kiel, DE

Reference:

von der Burchard, C., Moltmann, M., Tode, J. et al. Self-examination low-cost full-field OCT (SELFF-OCT) for patients with various macular diseases. Graefes Arch Clin Exp Ophthalmol 259, 1503–1511 (2021).

von der Burchard, C., et al., Self-Examination Low-Cost Full-Field Optical Coherence Tomography (SELFF-OCT) for neovascular age-related macular degeneration: a cross-sectional diagnostic accuracy study. BMJ Open, 2022. 12(6): p. e055082.

Role of the MLL: Consultancy

Clinical Partner: University Eye Hospital Bonn, University Hospital Bonn (UKB), DE

Reference:

Ratnam K, Domdei N, Harmening WM, Roorda A. Benefits of retinal image motion at the limits of spatial vision.­ J Vis. 2017;17(1):30.

Link to the study document at the German Clinical Trials Registry

Role of the MLL: Prototype and CRO

DRKS-ID of Study: DRKS00009350

Clinical Partner: Department of Ophthalmology, University Hospital Schleswig-Holstein Campus Kiel, DE

Role of the MLL: Prototype and CRO

Clinical Partner: Department of Urology, University Hospital Schleswig-Holstein Campus Lübeck, DE

Reference:

B. Lange, D. Jocham, R. Brinkmann, J. Cordes: Stone/tissue differentiation for Holmium laser lithotripsy using  autofluorescence: Clinical proof of concept study. Lasers in Surgery and Medicine 49(4):361-365, 2017.

Role of the MLL: Prototype

Clinical Partner: Department of Ophthalmology and Visual Science, College of Medicine, The Catholic University of Korea, Seoul, KOR

Reference:

Kang S, Park YG, Kim JR, Seifert E, Dirk TK, Ralf B, et al. Selective Retina Therapy in Patients With Chronic Central Serous Chorioretinopathy: A Pilot Study. Medicine (Baltimore). 2016;95(3):e2524.

Role of the MLL: Prototype and CRO

Clinical Partner: Department of Urology, University Hospital Schleswig-Holstein Campus Lübeck, DE

Reference:

Lange, D. Jocham, R. Brinkmann, J. Cordes: Stone/tissue differentiation during intracorporeal lithotripsy using diffuse white light reflectance spectroscopy: In vitro and clinical measurements. Lasers in Surgery and Medicine 46(8):614-619, 2014.

Role of the MLL: Prototype

Clinical Partner: Department of Ophthalmology and Visual Sciences, Osaka City University Graduate School of Medicine, JPN

Reference:

Yasui A, Yamamoto M, Hirayama K, Shiraki K, Theisen-Kunde D, Brinkmann R, et al. Retinal sensitivity after selective retina therapy (SRT) on patients with central serous chorioretinopathy. Graefes Arch Clin Exp Ophthalmol. 2016.

KUMIKO HIRAYAMA, MANABU YAMAMOTO, TAKEYA KOHNO, DIRK THEISEN-KUNDE, RALF BRINKMANN, YOKO MIURA, and SHIGERU HONDA, Change in the Thickness of Retinal Layers after Selective Retina Therapy (SRT) in Patients with Central Serous Chorioretinopathy, Osaka City Med. J. Vol. 65, 55-63, 2019

Role of the MLL: Prototype

Clinical Partner: Department of Ophthalmology, Inselspital Bern, CH

Reference:

Framme C, Walter A, Berger L, Prahs P, Alt C, Theisen-Kunde D, et al. Selective Retina Therapy in Acute and Chronic-Recurrent Central Serous Chorioretinopathy. Ophthalmologica. 2015;234(4):177-88.

Steiner P, Ebneter A, Berger LE, Zinkernagel M, Povazay B, Meier C, et al. Time-Resolved Ultra-High Resolution Optical Coherence Tomography for Real-Time Monitoring of Selective Retina Therapy. Invest Ophthalmol Vis Sci. 2015;56(11):6654-62.

Role of the MLL: Prototype

Clinical Partner: Department of Neurosurgery, University Hospital Schleswig-Holstein Campus Lübeck, DE

Reference:

Bohringer HJ, Lankenau E, Stellmacher F, Reusche E, Huttmann G, Giese A. Imaging of human brain tumor tissue by near-infrared laser coherence tomography. Acta Neurochir (Wien). 2009;151(5):507-17;

Giese A, Böhringer HJ, Leppert J, Kantelhardt SR, Lankenau E, Koch P, et al., Non-invasive intraoperative optical coherence tomography of the resection cavity during surgery of intrinsic brain tumors. SPIE BiOS; 2006: 

Clinical Partner: Department of ENT, University Hospital Schleswig-Holstein Campus Lübeck, DE

Reference:

Sommer K, Lankenau E, Hüttmann G, Fedder C, Thorns C, Raap M, et al. VERGLEICH ZWISCHEN AUTOFLUORESZENZ UND OPTISCHER KOHÄRENZTOMOGRAPHIE (OCT) ZUR DIAGNOSTIK VON PATHOLOGISCHEN VERÄNDERUNGEN DES LARYNX. HNO-Informationen (Kongressabstracts). 2005;84(01):254.

Role of the MLL: Prototype

Clinical Partner: Clinic and Polyclinic for Ophthalmology, University of Regensburg, DE

Reference:

Framme C, Walter A, Prahs P, Theisen-Kunde D, Brinkmann R. Comparison of threshold irradiances and online dosimetry for selective retina treatment (SRT) in patients treated with 200 nanoseconds and 1.7 microseconds laser pulses. Lasers in surgery and medicine. 2008;40(9):616-24.

Prahs P, Walter A, Regler R, Theisen-Kunde D, Birngruber R, Brinkmann R, et al. Selective retina therapy (SRT) in patients with geographic atrophy due to age-related macular degeneration. Graefes Arch Clin Exp Ophthalmol. 2010;248(5):651-8.

Role of the MLL: Prototype

Clinical Partner: Department of Obstetrics and Gynecology, University Hospital Schleswig-Holstein Campus Lübeck, DE

Reference:

M.Löning, E. Lankenau, H. Diddens, M. Krokowski, K. Diedrich, G. Hüttmann, Optische Kohärenztomographie in der Gynäkologie, Gynäkologe 2007 · 40:343–348

Role of the MLL: Prototype and CRO

Clinical Partner: 

Department of Ophthalmology, University Hospital Schleswig-Holstein Campus Kiel, DE

Department of Ophthalmology, University Hospital Schleswig-Holstein Campus Lübeck, DE

Ophthalmology Department, Guy’s and St Thomas’ Hospital, London, UK

Reference:

Elsner H, Klatt C, Liew SH, Porksen E, Bunse A, Rudolf M, et al. Selective retina therapy in patients with diabetic maculopathy. Ophthalmologe. 2006;103(10):856-60.

Brinkmann R, Roider J, Birngruber R. Selective retina therapy (SRT): a review on methods, techniques, preclinical and first clinical results. Bull Soc Belge Ophtalmol. 2006(302):51-69.

Role of the MLL: Prototype

Clinical Partner: Optical coherence tomography (OCT) for the diagnosis of urothelial carcinoma

Reference:

F. König, MINIMAL-INVASIVE DIAGNOSTIK DES UROTHELKARZINOMS MIT DEM SCHWERPUNKT ANWENDUNG NEUER BILDGEBENDER TECHNIKEN IN DER ENDOSKOPIE, Habilitationsschrift, Medizinischen Fakultät Charité der Humboldt-Universität zu Berlin, 2002

Daniltchenko D, König F, Lankenau E, Sachs M, Kristiansen G, Huettmann G, et al. Anwendung der optischen Kohärenztomographie (OCT) bei der Darstellung von Urothelerkrankungen der Harnblase. Der Radiologe. 2006;46(7):584-9.

Daniltchenko D, Lankenau E, Konig F, Shay B, Huettmann G, Sachs MD, et al. In vivo optical coherence tomography in endoscopic diagnostics of bladder disease. Biomedical Optics 2004; 2004: SPIE.

Role of the MLL: Prototype

Clinical Partner: Clinic and Polyclinic for Ophthalmology, University of Regensburg, DE

Reference:

Roider J, Brinkmann R, Wirbelauer C, Laqua H, Birngruber R. Retinal sparing by selective retinal pigment epithelial photocoagulation. Arch Ophthalmol. 1999;117(8):1028-34.