11 results
1. To characterize the efficacy of topical Fibrocaps plus gelatin sponge, as compared to gelatin sponge alone, in surgical subjects when control of mild to moderate bleeding by standard surgical techniques is ineffective and/or impractical2. To…
The primary objective of this trial is to investigate the safety of Fibrocaps* in subjects undergoing liver resection.The secondary objective of this study is to investigate the effectiveness of Fibrocaps* on time to achieve haemostasis and volume…
Prospective study: The potential use of intraoperative, ICG based, fluorescence imaging of LN's during CRC lymphadenectomy.
Feasibility study: The potential use of intraoperative, ICG based, fluorescence imaging of LN*s during CRC lymphadenectomy.
Detection of breast carcinoma with an ICG enhanced optical imaging device in breast cancer patients.
Ergonomics and function of the imaging system - the NIRF imaging system should not interfere with the standard lumpectomy procedure and used safely by the surgeon while detection of ICG within the tumour takes place. Duration: 1,5 hour clinical…
Primary: To demonstrate the superior efficacy of Nasalfent in the treatment of BTCP in opioid tolerant subjects who are receiving regular opioid therapy.Secondary: To demonstrate the safety, tolerability, and acceptability of Nasalfent in the…
The primary objective of the study is to demonstrate non-inferiority of an insulin regimen using insulin glargine as the basal insulin with Exubera as the mealtime insulin, compared to a regimen using insulin glargine as the basal insulin and…
To assess safety, tolerability and pharmacokinetics of a single subcutaneous administration of HPV-NIRD1.
The primary objective is to achieve intraoperative detection of histologically or cytologically proven GIST and metastases with ICG and NIR fluorescence imaging. The primary end-point is the diagnostic value of ICG in detecting GIST with NIR…
In this non-inferiority study, we aim to identify the diagnostic value of indocyanine green (ICG) fluorescence imaging for SLN mapping versus the standard-of-care 99mTc in the SLN procedure for breast cancer patients.
To evaluate the bilateral SLN detection rate of intraoperative ICG with NIR fluorescence imaging compared to the current standard of care of 99mTc (with preoperative SPECT/CT) and blue dye.