To assess the usability of a drop-in optical probe in terms of quality of optical measurements and impact on current workflow.
ID
Source
Brief title
Condition
- Male genital tract therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameter is the usability of a drop-in optical probe in terms
quality of measurements and impact on current workflow.
To assess the usability of the optical drop-in probe, we want to assess whether
the drop-in optical probe can make tissue contact at all prostate surfaces. To
measure this, we want to use single fiber reflectance measurements. These
single fiber reflectance measurements are performed automatically and
simultaneously with the diffuse reflection spectroscopy measurements and
measure a high reflection if there is no adequate tissue contact.
Secondary outcome
The secondary study parameter is ease of use of a drop-in DRS probe as reported
by surgeons. We intend to use the System Usability Scale (SUS-score) to assess
the ease of use as reported by surgeons.
For future research it is important to be able to mark the measurement
locations, so that the measurement location can be traced back in pathology
slides and so that it can be correlated to the acquired spectra. Therefor in
this study we want to assess which method, a suture or a clip, can best be used
to mark the measurement location in vivo and to find back the measurement
location in the pathology slides.
Background summary
Differences in optical characteristics between tumorous and healthy tissue
allow for the discrimination between tissue types. By performing Diffuse
Reflectance Spectroscopy (DRS) measurements at the resection margin, a surgeon
can detect and thus minimize positive resection margins during surgery. To use
this technique in vivo during Robot Assisted Laparoscopic Prostatectomies
(RALP) a drop-in optical DRS was designed.
Study objective
To assess the usability of a drop-in optical probe in terms of quality of
optical measurements and impact on current workflow.
Study design
Feasibility study
Study burden and risks
The study population for this study will consist of patients that receive robot
assisted laparoscopic prostatectomy for histologically proven prostate
carcinoma.
Participation in this study will not involve additional hospital visits,
physical examinations or tests, or the completion of questionnaires or diaries
for the patient.
The patient can give informed consent during one of the visits to the
outpatient clinic.
Measurements will involve the patient*s exposure to harmless light.
The process of measuring will add no more than 15 minutes to the total
operation time, during which patients will be under general anaesthesia.
Plesmanlaan 121
Amsterdam 1066 CX
NL
Plesmanlaan 121
Amsterdam 1066 CX
NL
Listed location countries
Age
Inclusion criteria
Men undergoing robot assisted laparoscopic prostatectomy for * T2 prostate
carcinoma, without neoadjuvant therapy
Exclusion criteria
- Suspected oversensitivity to light; e.g. a patient who has had photodynamic
therapy
- History of radiotherapy in the pelvic area
- History of abdominal surgery
- History of neoadjuvant androgen deprivation therapy
- Use of indocyanine green (ICG) injections prior to surgery
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL75036.031.20 |