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Study of the Diagnostic Efficacy of "Real Time" Niris 1300e Optical Coherence Tomography (OCT) Imaging System in the Management of Pre-invasive and Invasive Neoplasia of the Uterine Cervix (PUSHOCTII)


N/A
18 Years
N/A
Not Enrolling
Female
Cervical Intraepithelial Neoplasia, Cervix Cancer, Cervical Dysplasia, CIN, Human Papillomavirus

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Trial Information

Study of the Diagnostic Efficacy of "Real Time" Niris 1300e Optical Coherence Tomography (OCT) Imaging System in the Management of Pre-invasive and Invasive Neoplasia of the Uterine Cervix (PUSHOCTII)


B. Specific Aims

1. Primary. To determine the sensitivity, specificity, positive and negative predictive
values for Niris 1300e OCT enhanced gynecologic examination (VIA-OCT
vs.colposcopy-biopsy) for the detection of lesions equal or greater than cervical
intraepithelial neoplasia II (CIN II) and cancer in a "real time" clinical evaluation.

2. Secondary. To examine the ease of use of Niris 1300e OCT in a real time clinical
setting in order to assess its potential application during a "see and treat" or
"single episode of care" clinic visit.


Inclusion Criteria:



1. Female subjects > 18 years of age

2. Subject must voluntarily sign a Patient Informed Consent Form specific to the study.

3. Subject must be physically and mentally willing to comply with all study
requirements, especially conduct of a colposcopy exam.

4. Participant must be attending the Center for Cervical Diagnosis.

Exclusion Criteria:

1. Based on clinical history, physical exam and patient presentation, the subject is
unable to provide adequate informed consent and/or comply with the study
requirements.

2. Subject is a prisoner.

3. Subject is pregnant.

4. Subject has had a hysterectomy

5. Subject has received prior pelvic radiotherapy.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

To determine the accuracy of VIA plus Niris 1300e OCT enhanced gynecologic examination.

Outcome Time Frame:

Study will be completed over a 4 day period with OCT and brightness determination as each patient is seen. During the next 4 months, we will conduct blinded reviews of the images to determine new sets of brightness numbers.

Safety Issue:

No

Principal Investigator

Jerome L Belinson, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Preventive Oncology International

Authority:

China: Ethics Committee

Study ID:

PUSHOCTII

NCT ID:

NCT01766284

Start Date:

November 2012

Completion Date:

November 2012

Related Keywords:

  • Cervical Intraepithelial Neoplasia
  • Cervix Cancer
  • Cervical Dysplasia
  • CIN
  • Human Papillomavirus
  • Human Papillomavirus
  • Optical Coherence Tomography
  • Imaging Systems
  • Cervical intraepithelial neoplasia
  • Cervical Cancer
  • Cervical Dysplasia
  • Neoplasms
  • Uterine Cervical Neoplasms
  • Uterine Cervical Dysplasia
  • Cervical Intraepithelial Neoplasia
  • Carcinoma in Situ

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