Laparoscopic investigation of endometriosis using confocal endomicroscopy.

Women with symptoms of endometriosis who are indicated for diagnostic or therapeutic surgery undergo in vivo microscopic imaging of endometriosis lesions for comparison with conventional histopathological analysis of biopsied lesions to assess the diagnostic potential of endomicroscopy in identifying lesions prior to therapeutic intervention.

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12607000496415

Enrollment

Registered

2007-09-27

Start date

2007-10-30

Completion date

Unknown

Last updated

2020-01-13

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

Conditions

None listed

Brief summary

The study aims to evaluate the diagnostic accuracy of a new cellular imaging device for identifying endometriosis lesions during surgery which require treatment or removal.

Interventions

Confocal endomicroscopy In vivo microscopic imaging using an intravenously administered fluorescent contrast agent (Fluorescein Sodium 10%), is performed during the participant's therapeutic or diagnostic surgery. Depending upon the number of lesions identified, endomicroscopic imaging is expected to add 10-20 minutes to each participant's laparoscopic surgery (1 session per participant).

Study design

Allocation

Non-randomised trial

Intervention model

Single group

Primary purpose

Diagnosis

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to -2147483648 No limit

Healthy volunteers

Inclusion criteria

Women of reproductive age with symptoms consistent with endometriosis (including painful periods, pelvic pain, painful intercourse) who are indicated for diagnostic or therapeutic laparoscopy. English speaking background.

Exclusion criteria

Women under the age of 18 years. Patients with inadequate English. Patients who are mentally or legally incapacitated or unable to give informed consent. Allergy or prior adverse reaction to Fluorescein Sodium.

Outcome results