Trial Outcomes & Findings for Pilot Study: Can Ultrasound Guided Biopsy be Used as an Alternative to Hysteroscopy? (NCT NCT03207126)

NCT ID: NCT03207126

Last Updated: 2024-11-25

Results Overview

All samples taken using ultrasound guided biopsy were analysed by histology lab. If they had sufficient tissue to give a diagnosis (benign, pre-malignant or malignant) this was deemed successful. It is deemed successful if there was sufficient tissue to give a histological analysis. So overall there will be a percentage success rate (number of tissue samples sufficient/number of tissue samples taken). Each patient would have had one sample.

Recruitment status

COMPLETED

Study phase

Target enrollment

10 participants

Primary outcome timeframe

1.5 years

Results posted on

2024-11-25

Participant Flow

Unit of analysis: samples

Participant milestones

Participant milestones
Measure	Women Needing Endometrial Biopsy All women who would be offered hysteroscopy guided biopsy as standard of care will be offered ultrasound guided biopsy first. Ultrasound guided biopsy: For women needed a hysteroscopy guided biopsy as part of routine standard of care, women will now receive an ultrasound guided biopsy first
Overall Study STARTED	10 10
Overall Study COMPLETED	10 10
Overall Study NOT COMPLETED	0 0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Women Needing Endometrial Biopsy n=10 Participants All women who would be offered hysteroscopy guided biopsy as standard of care will be offered ultrasound guided biopsy first. Ultrasound guided biopsy: For women needed a hysteroscopy guided biopsy as part of routine standard of care, women will now receive an ultrasound guided biopsy first
Age, Categorical <=18 years	0 Participants n=10 Participants
Age, Categorical Between 18 and 65 years	6 Participants n=10 Participants
Age, Categorical >=65 years	4 Participants n=10 Participants
Age, Continuous	61 years n=10 Participants
Sex: Female, Male Female	10 Participants n=10 Participants
Sex: Female, Male Male	0 Participants n=10 Participants
Region of Enrollment United Kingdom	10 participants n=10 Participants
Pain score	7.5 units on a scale n=10 Participants
Number of participants providing a tissue sample	9 Participants n=10 Participants

PRIMARY outcome

Timeframe: 1.5 years

Outcome measures

Outcome measures
Measure	Women Needing Endometrial Biopsy n=10 Participants All women who would be offered hysteroscopy guided biopsy as standard of care will be offered ultrasound guided biopsy first. Ultrasound guided biopsy: For women needed a hysteroscopy guided biopsy as part of routine standard of care, women will now receive an ultrasound guided biopsy first
Number of Participants Whose Sample Was Successfully Analysed by Histological Diagnosis	9 Participants

SECONDARY outcome

Timeframe: 1.5 years

Visual analogue score will be given to patients post procedure to assess tolerability of the procedure. The full score scale ranges from 0 to 10 that means from no pain (0) to worst pain they ever had (10).

Outcome measures

Outcome measures
Measure	Women Needing Endometrial Biopsy n=10 Participants All women who would be offered hysteroscopy guided biopsy as standard of care will be offered ultrasound guided biopsy first. Ultrasound guided biopsy: For women needed a hysteroscopy guided biopsy as part of routine standard of care, women will now receive an ultrasound guided biopsy first
Patient Satisfaction of Ultrasound Guided Biopsy by Questionnaire	7.5 score on a scale Interval 4.0 to 10.0

Adverse Events

Women Needing Endometrial Biopsy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Diana Marcus

Imperial College London

Phone: 07525133957

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place