Trial Outcomes & Findings for HOME Study: Hysteroscopic Office Myomectomy Evaluation (NCT NCT01152112)

Results Overview

Percent reduction in target pathology volume, compared between pre-treatment baseline and 3 months post MyoSure treatment

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

74 participants

Primary outcome timeframe

Three months post treatment

Results posted on

2017-09-13

Participant Flow

Participant milestones

Participant milestones
Measure	Treatment, Office Setting, Myomectomy Myomectomy for uterine polyps and/or fibroids occurring in an office setting	Treatment, Hospital Setting, Myomectomy Myomectomy for uterine polyps and/or fibroids occurring in a hospital setting
Overall Study STARTED	42	32
Overall Study COMPLETED	42	32
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

HOME Study: Hysteroscopic Office Myomectomy Evaluation

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment, Office Setting, Myomectomy n=42 Participants Myomectomy for uterine polyps and/or fibroids occurring in an office setting Myomectomy: Removal of fibroids and / or polyps	Treatment, Hospital Setting, Myomectomy n=32 Participants Myomectomy for uterine polyps and/or fibroids occurring in a hospital setting Myomectomy: Removal of fibroids and / or polyps	Total n=74 Participants Total of all reporting groups
Sex: Female, Male Female	42 Participants n=5 Participants	32 Participants n=7 Participants	74 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	42 Participants n=5 Participants	32 Participants n=7 Participants	74 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	42 participants n=5 Participants	32 participants n=7 Participants	74 participants n=5 Participants

PRIMARY outcome

Timeframe: Three months post treatment

Population: A total of 108 pathologies were removed in 74 patients. Among the 108 pathologies removed, 53 were removed in the office setting (28 myomas, 25 polyps) and 55 were removed in the ASC setting (14 myomas, 41 polyps).

Percent reduction in target pathology volume, compared between pre-treatment baseline and 3 months post MyoSure treatment

Outcome measures

Outcome measures
Measure	Treatment, Office Setting, Myomectomy n=53 Fibroids and Polyps Myomectomy for uterine polyps and/or fibroids occurring in an office setting Myomectomy: Removal of fibroids and / or polyps	Treatment, Hospital Setting, Myomectomy n=55 Fibroids and Polyps Myomectomy for uterine polyps and/or fibroids occurring in a hospital setting Myomectomy: Removal of fibroids and / or polyps
Percent Reduction in Target Pathology Volume	96.9 percentage of fibriods/polyps Interval 90.3 to 103.5	99.9 percentage of fibriods/polyps Interval 99.6 to 100.2

SECONDARY outcome

Timeframe: Three months post treatment

Percent volume reduction of target pathology between baseline and month three post treatment assessments, as measured by saline infused sonohysterogram.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 1 hour post treatment

Mean difference in pain score compared between subject-rated assessment of pain occurring during a pap smear and pain occurring during the MyoSure treatment procedure, based on the Wong-Baker Faces Rating Scale (FRS)

Outcome measures

Outcome data not reported

Adverse Events

Treatment, Office Setting, Myomectomy

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Treatment, Hospital Setting, Myomectomy

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Treatment, Office Setting, Myomectomy n=42 participants at risk Myomectomy for uterine polyps and/or fibroids occurring in an office setting Myomectomy: Removal of fibroids and / or polyps	Treatment, Hospital Setting, Myomectomy n=32 participants at risk Myomectomy for uterine polyps and/or fibroids occurring in a hospital setting Myomectomy: Removal of fibroids and / or polyps
Gastrointestinal disorders Food Poisoning	0.00% 0/42 • Adverse effect information was collected throughout the study. All adverse effects were monitored until they were adequately resolved or explained.	3.1% 1/32 • Number of events 1 • Adverse effect information was collected throughout the study. All adverse effects were monitored until they were adequately resolved or explained.
Gastrointestinal disorders Diarrhea	0.00% 0/42 • Adverse effect information was collected throughout the study. All adverse effects were monitored until they were adequately resolved or explained.	3.1% 1/32 • Number of events 1 • Adverse effect information was collected throughout the study. All adverse effects were monitored until they were adequately resolved or explained.
General disorders Pain	2.4% 1/42 • Number of events 1 • Adverse effect information was collected throughout the study. All adverse effects were monitored until they were adequately resolved or explained.	0.00% 0/32 • Adverse effect information was collected throughout the study. All adverse effects were monitored until they were adequately resolved or explained.

Additional Information

Christina Mastandrea / Clinical Research manager

Hologic, Inc.

Phone: 5082638772

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place