GONDOLA: Gonorrhoea detection using laboratory assessment

A single-centre, prospective evaluative study to investigate the performance of the Bio Med InTray® GC (a sample collection, transport and culture in-vitro device), compared to current standard methods, to microbiologically detect Neisseria gonorrhoeae

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN16307168

Enrollment

Registered

2020-03-05

Start date

2019-04-29

Completion date

Unknown

Last updated

2020-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gonococcal infection Infections and Infestations Gonococcal infection

Interventions

Participants will be asked to provide a swab sample (vaginal/cervix/rectal swabs for women and urethral/rectal swabs for men) as per normal practice to test for N gonorrhoeae infection. The samples wi

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Presenting to sexual health clinic with symptom(s) of Neisseria gonorrhoeae infection, presence of urethral or vaginal discharge and/or dysuria OR 2. Recent medical history and risk factors that in the opinion of the treating clinician warrants investigation for N. gonorrhoeae infection

Exclusion criteria

Exclusion criteria: 1. Under the age of 18 years 2. Unable to fully understand the consent process and provide informed consent due to either language barriers or mental capacity

Design outcomes

Primary

Measure	Time frame
Detection rates of gonococcal infection assessed by microbiology laboratory diagnostic testing	—

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026