- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT02321995
A Quantitative Optical Sensor to Monitor Vascular Physiology; A Healthy Volunteer Study
Panoramica dello studio
Stato
Condizioni
Descrizione dettagliata
PURPOSE OF THE STUDY:
- There exist significant systematic and random errors in the in vivo spectroscopic measurement of tissue hemoglobin concentrations, blood oxygenation, and scattering coefficient due to uncontrolled probe-to-tissue interface and the lack of a real-time calibration.
- It is possible to design and engineer a fiber optic sensor to perform accurate and reproducible diffuse reflectance spectroscopy (DRS) for noninvasive quantification of tissue physiology and morphology in vivo. Features such as probe pressure control and instrument self-calibration will improve signal-to-noise ratios by removing user bias from optical measurements.
STUDY OBJECTIVES
1) Evaluation of the pressure sensor in healthy volunteers to determine the minimum contact pressure required for spectroscopic measurements
DESIGN AND PROCEDURES:
Evaluation of the pressure sensor in a volunteer study (n=10)
Informed consent will be obtained from all volunteers. In order to assess the pressure sensor, all research procedures will be repeated twice (once with the aid of the stepper motor and once without the aid of the stepper motor.) For the first five subjects, measurements will be made with the stepper motor first followed by measurements without the stepper motor. The remaining five-subjects will receive the measurements in the reverse order (no stepper motor following by stepper motor). Before the optical measurements, all subjects will be asked to rinse their mouth with a 0.9% saline solution in order to minimize the influence of consumed food. The instrument is high-level disinfected prior to each use in cidex or sterilized by ethylene oxide per standard clinical procedure. Furthermore, it is not anticipated that this device will pose a significant risk to vulnerable populations. The probe will be covered with an optically clear protective sterile sheath and placed in contact with the soft tissue. Reflectance measurements will be taken from each volunteer at up to 5 pressure levels (25, 50, 75, 100, 150 mmHg). At each pressure level 10 spectra will be acquired sequentially. The first measurement will start immediately after the desired probe pressure is reached. This will generate a total of 100 sample and calibration spectra pairs from each subject. This will be repeated on other sites including the tongue, cheek and gums. The sample spectrum will be calibrated using the calibration spectrum collected concurrently. Three tissue parameters will be used to analyze the pressure effects which is described here with [THb] as an example: First, the mean [THb] and its standard deviation will be calculated from the 10 repeat measurements at each pressure for each subject for measurements with and without the stepper motor and plotted against the probe pressure (refer to as THb-P curve). Second, at each pressure level, the [THb] will be plotted against time for each subject and the curve will indicate the temporal response of the tissue under that probe pressure. A series of paired t-tests will be used to identify the contact pressure at which minimal [THb] variance occurs over time (when stepper motor is used). Next, the variance at that contact pressure will be compared to the case without the stepper motor to demonstrate a significant reduction in pressure variance.
The investigators do not anticipate any risks to participants, however, there are a few potential minimal risks such as loss of confidentiality; slight risk of infection; discomfort at the pressure sites; and jaw discomfort as a result of the mouth being opened for several minutes.
Tipo di studio
Iscrizione (Effettivo)
Contatti e Sedi
Luoghi di studio
-
-
North Carolina
-
Durham, North Carolina, Stati Uniti, 27705
- Duke University Medical Center
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
Descrizione
Inclusion Criteria:
- Healthy volunteer with no presentation of disease (such as no complaints or self-reported oral symptoms or lesions; no cold or flu like symptoms) that would affect the reflective measurements in the oral cavity
- Age 18 or older
- Subjects of all ethnic and gender groups will be included
- Ability to understand and the willingness to sign a written informed consent document
Exclusion Criteria:
- Subjects considered in "vulnerable" populations such as children under the age of 18
- Complaint of oral symptoms or lesions
- Current cold or flu like symptoms (self-reported)
- Pregnancy (self-reported by menstrual history)
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
---|---|
minimum contact pressure required for spectroscopic measurements
Lasso di tempo: at the time the optical measurements are collected
|
at the time the optical measurements are collected
|
Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Mark Dewhirst, DVM, PhD, Duke University
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Altri numeri di identificazione dello studio
- Pro00057177
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .