Performance Proof of Product Developed to Detect Abnormal Vaginal pH

NCT01542606 | Withdrawn DMC

• 1 other identifier: F-7-28.6-1
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

This study was designed to validate the color appearance on the NORMA-SENSE gen 3 when comes into contact with vaginal secretions having an elevated pH level

Conditions

Vaginal Infection

Keywords

PH; SCREENING; EARLY WARNING; VAGINAL HEALTH; VAGINAL SECRETION; VAGINAL PH

Outcome Measures

Primary Outcomes (1)

• color status of the NORMA-SENSE gen 3 and the pH measurement.

  agreement between the color status of the NORMA-SENSE gen 3 as reported by the subject after using the panty liners, and the pH measurement with Nitrazine paper.

  3 days

Secondary Outcomes (1)

• physical comfort in using NORMA-SENSE gen 3 and the result reading clarity

  3 days

Study Arms (1)

color status

EXPERIMENTAL

The NORMA-SENSE gen 3 polymer matrix is stained by blue or green color on a pale yellow background when the pH level of the fluid in contact with it is greater than the cutoff value, and the user can consider any stain of color, which is different from the original background, as a positive result of the test.

Device: NORMA-SENSE

Interventions

NORMA-SENSE DEVICE

The NORMA-SENSE gen 3 polymer matrix is stained by blue or green color on a pale yellow background when the pH level of the fluid in contact with it is greater than the cutoff value, and the user can consider any stain of color, which is different from the original background, as a positive result of the test.

color status

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women, age 18 years or greater with or without symptoms of vaginal infection.
• Subject is ready to sign the informed consent form.

You may not qualify if:

• Subject is unable or unwilling to cooperate with study procedures.
• Subject is currently participating in another clinical study.
• Subject suffers from vaginal bleeding or is menstruating.
• Subject that have had sexual relations within the last 12 hours.
• Subject that applied local antiseptic or antibiotic or vaginal treatment within the last 3 days.
• Subject that applied vaginal douching within 12 hours prior to the visit at the clinic.

Sponsors & Collaborators

• Common Sense: lead

Study Sites (1)

Lin Medical Center Clalit health care

Haifa, Israel

Location

MeSH Terms

Conditions

Vaginitis

Condition Hierarchy (Ancestors)

Vaginal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Hadar Kessary, PhD

  Common Sense

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 21, 2012
• First Posted: March 2, 2012
• Study Start: March 1, 2019
• Primary Completion: September 1, 2019
• Study Completion: December 1, 2019
• Last Updated: October 31, 2019

Record last verified: 2019-08

Locations

IL (1)