Compare Fallopian Tube Cells Collected by Cytuity With Removed Ovarian/Tubal Tissue to Determine Presence of Malignancy
Purpose
Prospective, multi-center, non-randomized study to assess the ability of the Cytuity device to collect cell samples from the fallopian tube that can be evaluated for the presence or absence of malignancy.
Conditions
- Fallopian Tube Cancer
- Ovarian Cancer
- Ovarian Neoplasms
- Ovary Cancer
- Fallopian Tube Neoplasms
- Fallopian Tube Adenocarcinoma
- High Grade Serous Carcinoma
- Peritoneal Carcinoma
- Peritoneal Neoplasms
- Adnexal Mass
- Ovarian Diseases
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Subject is medically cleared for surgery 2. Subject is scheduled to undergo salpingo-oophorectomy or salpingectomy for a pelvic mass suspicious for malignancy 3. Subject must be 18 years of age 4. Subject must be able to provide informed consent
Exclusion Criteria
- Contraindication to hysteroscopy 2. Acute pelvic inflammatory disease 3. Active or recent lower pelvic infection 4. Pregnancy 5. Delivery or termination of a pregnancy in the past 6 weeks 6. Known tubal obstruction 7. Tubal ligation 8. Invasive carcinoma of the cervix or endometrium 9. Intolerance of anesthesia
Study Design
- Phase
- Study Type
- Observational
- Observational Model
- Case-Only
- Time Perspective
- Prospective
More Details
- Status
- Completed
- Sponsor
- Boston Scientific Corporation