Trial Outcomes & Findings for ESS505 Pre-hysterectomy Protocol (NCT NCT01664052)

NCT ID: NCT01664052

Last Updated: 2016-08-04

Results Overview

Hysterosalpingogram (HSG) is an x-ray of the uterus and fallopian tubes after the injection of a contrast material (dye). This test evaluates tubal occlusion. ESS505 and ESS505-A inserts are designed with the addition of an articulated hydrogel plug bonded to the distal portion of the insert with surgical grade adhesive and a nitinol support wire that remains inside the distal inner coil.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 66 participants
• Primary outcome timeframe: 60 days after insert placement
• Results posted on: 2016-08-04

Participant Flow

66 participants were enrolled in two centers.

Participant milestones

Measure	ESS505-A (Essure, BAY1454033) Bilateral hysteroscopic placement of the permanent birth control system, Model ESS505 insert with minimal polyethylene terephthalate (PET) fibers (investigational device model ESS505-A) followed by tubal occlusion evaluation by hysterosalpingogram (HSG) approximately 60 minutes following insert placement. A subsequent HSG was performed prior to the subjects' scheduled hysterectomy procedures at 30 (group 3), 60 (group 2) or 90 days (group 1) post insert placement.	ESS 305/ESS 505 (Essure, BAY1454032/Essure, BAY1454033) Unilateral hysteroscopic placement of the permanent birth control system, Model ESS505 insert inclusive of polyethylene terephthalate (PET) fibers (investigational device model ESS505) and contralateral placement of the current commercially approved Essure device, model ESS305 followed by tubal occlusion evaluation by hysterosalpingogram (HSG) approximately 60 minutes following insert placement. A subsequent HSG was performed prior to the subjects' scheduled hysterectomy procedures at 30 (group 3), 60 (group 2) or 90 days (group 1) post insert placement. At the conclusion of the hysterectomy, the uterine cornua and fallopian tubes were sent to a pathology lab for histological preparation, and subsequent evaluation.
Phase 1 STARTED	31	0
Phase 1 Insert Placed in at Least One Tube	25	0
Phase 1 HSG 1 Hour Post Placement	24	0
Phase 1 Repeat HSG and Hysterectomy at 30 Days	9	0
Phase 1 Repeat HSG and Hysterectomy at 60 Days	8	0
Phase 1 Repeat HSG and Hysterectomy at 90 Days	7	0
Phase 1 COMPLETED	24	0
Phase 1 NOT COMPLETED	7	0
Phase 2 STARTED	0	35
Phase 2 Insert Placed	0	31
Phase 2 HSG 1 Hour Post Placement	0	31
Phase 2 Repeat HSG and Hysterectomy at 30 Days	0	10
Phase 2 Repeat HSG and Hysterectomy at 60 Days	0	10
Phase 2 Repeat HSG and Hysterectomy at 90 Days	0	10
Phase 2 COMPLETED	0	31
Phase 2 NOT COMPLETED	0	4

Reasons for withdrawal

Measure	ESS505-A (Essure, BAY1454033) Bilateral hysteroscopic placement of the permanent birth control system, Model ESS505 insert with minimal polyethylene terephthalate (PET) fibers (investigational device model ESS505-A) followed by tubal occlusion evaluation by hysterosalpingogram (HSG) approximately 60 minutes following insert placement. A subsequent HSG was performed prior to the subjects' scheduled hysterectomy procedures at 30 (group 3), 60 (group 2) or 90 days (group 1) post insert placement.	ESS 305/ESS 505 (Essure, BAY1454032/Essure, BAY1454033) Unilateral hysteroscopic placement of the permanent birth control system, Model ESS505 insert inclusive of polyethylene terephthalate (PET) fibers (investigational device model ESS505) and contralateral placement of the current commercially approved Essure device, model ESS305 followed by tubal occlusion evaluation by hysterosalpingogram (HSG) approximately 60 minutes following insert placement. A subsequent HSG was performed prior to the subjects' scheduled hysterectomy procedures at 30 (group 3), 60 (group 2) or 90 days (group 1) post insert placement. At the conclusion of the hysterectomy, the uterine cornua and fallopian tubes were sent to a pathology lab for histological preparation, and subsequent evaluation.
Phase 1 No device placement	6	0
Phase 1 No HSG 1 hr post placement	1	0
Phase 2 No device placement	0	4

Baseline Characteristics

ESS505 Pre-hysterectomy Protocol

Baseline characteristics by cohort

Measure	ESS505-A n=31 Participants Bilateral placement of Essure 505A (BAY1454033) insert (with minimal PET fiber).	ESS305/ESS505 n=35 Participants Unilateral placement of Essure 505 (BAY1454033) insert (PET-inclusive) and Contralateral placement of the current commercial Essure device Essure 305 (BAY1454032)	Total n=66 Participants Total of all reporting groups
Age, Continuous	42 Years n=5 Participants	40 Years n=7 Participants	41 Years n=5 Participants
Sex: Female, Male Female	31 Participants n=5 Participants	35 Participants n=7 Participants	66 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 60 minutes after insert placement

Hysterosalpingogram (HSG) is an x-ray of the uterus and fallopian tubes after the injection of a contrast material (dye). This test evaluates tubal occlusion.

Outcome measures

Measure	ESS505-A (Essure, BAY1454033) n=39 Fallopian tubes Bilateral hysteroscopic placement of the permanent birth control system, Model ESS505 insert with minimal polyethylene terephthalate (PET) fibers (investigational device model ESS505-A) followed by tubal occlusion evaluation by hysterosalpingogram (HSG) approximately 60 minutes following insert placement. A subsequent HSG was performed prior to the subjects' scheduled hysterectomy procedures at 30 (group 3), 60 (group 2) or 90 days (group 1) post insert placement.	ESS305 (Essure, BAY1454032) n=31 Fallopian tubes Unilateral hysteroscopic placement of the permanent birth control system, Model ESS505 insert inclusive of polyethylene terephthalate (PET) fibers (investigational device model ESS505) and contralateral placement of the current commercially approved Essure device, model ESS305 followed by tubal occlusion evaluation by hysterosalpingogram (HSG) approximately 60 minutes following insert placement. A subsequent HSG was performed prior to the subjects' scheduled hysterectomy procedures at 30 (group 3), 60 (group 2) or 90 days (group 1) post insert placement. At the conclusion of the hysterectomy, the uterine cornua and fallopian tubes were sent to a pathology lab for histological preparation, and subsequent evaluation.	ESS505 (Essure, BAY1454033) n=29 Fallopian tubes Unilateral hysteroscopic placement of the permanent birth control system, Model ESS505 insert inclusive of polyethylene terephthalate (PET) fibers (investigational device model ESS505) and contralateral placement of the current commercially approved Essure device, model ESS305 followed by tubal occlusion evaluation by hysterosalpingogram (HSG) approximately 60 minutes following insert placement. A subsequent HSG was performed prior to the subjects' scheduled hysterectomy procedures at 30 (group 3), 60 (group 2) or 90 days (group 1) post insert placement. At the conclusion of the hysterectomy, the uterine cornua and fallopian tubes were sent to a pathology lab for histological preparation, and subsequent evaluation.
Number of Occluded Fallopian Tubes 60 Minutes After Placement of the Insert as Measured by an HSG Evaluation ESS505-A	36 Occluded fallopian tubes	NA Occluded fallopian tubes ESS505-A not investigated in this group	NA Occluded fallopian tubes ESS505-A not investigated in this group
Number of Occluded Fallopian Tubes 60 Minutes After Placement of the Insert as Measured by an HSG Evaluation ESS305	NA Occluded fallopian tubes ESS305 not investigated in this group	3 Occluded fallopian tubes	NA Occluded fallopian tubes ESS305 not investigated in this group
Number of Occluded Fallopian Tubes 60 Minutes After Placement of the Insert as Measured by an HSG Evaluation ESS505	NA Occluded fallopian tubes ESS505 not investigated in this group	NA Occluded fallopian tubes ESS505 not investigated in this group	28 Occluded fallopian tubes

PRIMARY outcome

Timeframe: 30 days after insert placement

Hysterosalpingogram (HSG) is an x-ray of the uterus and fallopian tubes after the injection of a contrast material (dye). This test evaluates tubal occlusion. ESS505 and ESS505-A inserts are designed with the addition of an articulated hydrogel plug bonded to the distal portion of the insert with surgical grade adhesive and a nitinol support wire that remains inside the distal inner coil.

Outcome measures

Measure	ESS505-A (Essure, BAY1454033) n=15 Fallopian tubes Bilateral hysteroscopic placement of the permanent birth control system, Model ESS505 insert with minimal polyethylene terephthalate (PET) fibers (investigational device model ESS505-A) followed by tubal occlusion evaluation by hysterosalpingogram (HSG) approximately 60 minutes following insert placement. A subsequent HSG was performed prior to the subjects' scheduled hysterectomy procedures at 30 (group 3), 60 (group 2) or 90 days (group 1) post insert placement.	ESS305 (Essure, BAY1454032) n=10 Fallopian tubes Unilateral hysteroscopic placement of the permanent birth control system, Model ESS505 insert inclusive of polyethylene terephthalate (PET) fibers (investigational device model ESS505) and contralateral placement of the current commercially approved Essure device, model ESS305 followed by tubal occlusion evaluation by hysterosalpingogram (HSG) approximately 60 minutes following insert placement. A subsequent HSG was performed prior to the subjects' scheduled hysterectomy procedures at 30 (group 3), 60 (group 2) or 90 days (group 1) post insert placement. At the conclusion of the hysterectomy, the uterine cornua and fallopian tubes were sent to a pathology lab for histological preparation, and subsequent evaluation.	ESS505 (Essure, BAY1454033) n=10 Fallopian tubes Unilateral hysteroscopic placement of the permanent birth control system, Model ESS505 insert inclusive of polyethylene terephthalate (PET) fibers (investigational device model ESS505) and contralateral placement of the current commercially approved Essure device, model ESS305 followed by tubal occlusion evaluation by hysterosalpingogram (HSG) approximately 60 minutes following insert placement. A subsequent HSG was performed prior to the subjects' scheduled hysterectomy procedures at 30 (group 3), 60 (group 2) or 90 days (group 1) post insert placement. At the conclusion of the hysterectomy, the uterine cornua and fallopian tubes were sent to a pathology lab for histological preparation, and subsequent evaluation.
Number of Occluded Fallopian Tubes 30 Days Following Placement as Measured by an HSG Evaluation ESS505-A	15 Occluded fallopian tubes	NA Occluded fallopian tubes ESS505-A not investigated in this group	NA Occluded fallopian tubes ESS505-A not investigated in this group
Number of Occluded Fallopian Tubes 30 Days Following Placement as Measured by an HSG Evaluation ESS305	NA Occluded fallopian tubes ESS305 not investigated in this group	10 Occluded fallopian tubes	NA Occluded fallopian tubes ESS305 not investigated in this group
Number of Occluded Fallopian Tubes 30 Days Following Placement as Measured by an HSG Evaluation ESS505	NA Occluded fallopian tubes ESS505 not investigated in this group	NA Occluded fallopian tubes ESS505 not investigated in this group	10 Occluded fallopian tubes

PRIMARY outcome

Timeframe: 60 days after insert placement

Hysterosalpingogram (HSG) is an x-ray of the uterus and fallopian tubes after the injection of a contrast material (dye). This test evaluates tubal occlusion. ESS505 and ESS505-A inserts are designed with the addition of an articulated hydrogel plug bonded to the distal portion of the insert with surgical grade adhesive and a nitinol support wire that remains inside the distal inner coil.

Outcome measures

Measure	ESS505-A (Essure, BAY1454033) n=13 Fallopian tubes Bilateral hysteroscopic placement of the permanent birth control system, Model ESS505 insert with minimal polyethylene terephthalate (PET) fibers (investigational device model ESS505-A) followed by tubal occlusion evaluation by hysterosalpingogram (HSG) approximately 60 minutes following insert placement. A subsequent HSG was performed prior to the subjects' scheduled hysterectomy procedures at 30 (group 3), 60 (group 2) or 90 days (group 1) post insert placement.	ESS305 (Essure, BAY1454032) n=10 Fallopian tubes Unilateral hysteroscopic placement of the permanent birth control system, Model ESS505 insert inclusive of polyethylene terephthalate (PET) fibers (investigational device model ESS505) and contralateral placement of the current commercially approved Essure device, model ESS305 followed by tubal occlusion evaluation by hysterosalpingogram (HSG) approximately 60 minutes following insert placement. A subsequent HSG was performed prior to the subjects' scheduled hysterectomy procedures at 30 (group 3), 60 (group 2) or 90 days (group 1) post insert placement. At the conclusion of the hysterectomy, the uterine cornua and fallopian tubes were sent to a pathology lab for histological preparation, and subsequent evaluation.	ESS505 (Essure, BAY1454033) n=9 Fallopian tubes Unilateral hysteroscopic placement of the permanent birth control system, Model ESS505 insert inclusive of polyethylene terephthalate (PET) fibers (investigational device model ESS505) and contralateral placement of the current commercially approved Essure device, model ESS305 followed by tubal occlusion evaluation by hysterosalpingogram (HSG) approximately 60 minutes following insert placement. A subsequent HSG was performed prior to the subjects' scheduled hysterectomy procedures at 30 (group 3), 60 (group 2) or 90 days (group 1) post insert placement. At the conclusion of the hysterectomy, the uterine cornua and fallopian tubes were sent to a pathology lab for histological preparation, and subsequent evaluation.
Number of Occluded Fallopian Tubes 60 Days Following Placement as Measured by an HSG Evaluation ESS505-A	12 Occluded fallopian tubes	NA Occluded fallopian tubes ESS505-A not investigated in this group	NA Occluded fallopian tubes ESS505-A not investigated in this group
Number of Occluded Fallopian Tubes 60 Days Following Placement as Measured by an HSG Evaluation ESS305	NA Occluded fallopian tubes ESS305 not investigated in this group	10 Occluded fallopian tubes	NA Occluded fallopian tubes ESS305 not investigated in this group
Number of Occluded Fallopian Tubes 60 Days Following Placement as Measured by an HSG Evaluation ESS505	NA Occluded fallopian tubes ESS505 not investigated in this group	NA Occluded fallopian tubes ESS505 not investigated in this group	9 Occluded fallopian tubes

PRIMARY outcome

Timeframe: 90 days after insert placement

Hysterosalpingogram (HSG) is an x-ray of the uterus and fallopian tubes after the injection of a contrast material (dye). This test evaluates tubal occlusion. ESS505 and ESS505-A inserts are designed with the addition of an articulated hydrogel plug bonded to the distal portion of the insert with surgical grade adhesive and a nitinol support wire that remains inside the distal inner coil.

Outcome measures

Measure	ESS505-A (Essure, BAY1454033) n=11 Fallopian tubes Bilateral hysteroscopic placement of the permanent birth control system, Model ESS505 insert with minimal polyethylene terephthalate (PET) fibers (investigational device model ESS505-A) followed by tubal occlusion evaluation by hysterosalpingogram (HSG) approximately 60 minutes following insert placement. A subsequent HSG was performed prior to the subjects' scheduled hysterectomy procedures at 30 (group 3), 60 (group 2) or 90 days (group 1) post insert placement.	ESS305 (Essure, BAY1454032) n=10 Fallopian tubes Unilateral hysteroscopic placement of the permanent birth control system, Model ESS505 insert inclusive of polyethylene terephthalate (PET) fibers (investigational device model ESS505) and contralateral placement of the current commercially approved Essure device, model ESS305 followed by tubal occlusion evaluation by hysterosalpingogram (HSG) approximately 60 minutes following insert placement. A subsequent HSG was performed prior to the subjects' scheduled hysterectomy procedures at 30 (group 3), 60 (group 2) or 90 days (group 1) post insert placement. At the conclusion of the hysterectomy, the uterine cornua and fallopian tubes were sent to a pathology lab for histological preparation, and subsequent evaluation.	ESS505 (Essure, BAY1454033) n=10 Fallopian tubes Unilateral hysteroscopic placement of the permanent birth control system, Model ESS505 insert inclusive of polyethylene terephthalate (PET) fibers (investigational device model ESS505) and contralateral placement of the current commercially approved Essure device, model ESS305 followed by tubal occlusion evaluation by hysterosalpingogram (HSG) approximately 60 minutes following insert placement. A subsequent HSG was performed prior to the subjects' scheduled hysterectomy procedures at 30 (group 3), 60 (group 2) or 90 days (group 1) post insert placement. At the conclusion of the hysterectomy, the uterine cornua and fallopian tubes were sent to a pathology lab for histological preparation, and subsequent evaluation.
Number of Occluded Fallopian Tubes 90 Days Following Placement as Measured by an HSG Evaluation ESS505-A	10 Occluded fallopian tubes	NA Occluded fallopian tubes ESS505-A not investigated in this group	NA Occluded fallopian tubes ESS505-A not investigated in this group
Number of Occluded Fallopian Tubes 90 Days Following Placement as Measured by an HSG Evaluation ESS305	NA Occluded fallopian tubes ESS305 not investigated in this group	10 Occluded fallopian tubes	NA Occluded fallopian tubes ESS305 not investigated in this group
Number of Occluded Fallopian Tubes 90 Days Following Placement as Measured by an HSG Evaluation ESS505	NA Occluded fallopian tubes ESS505 not investigated in this group	NA Occluded fallopian tubes ESS505 not investigated in this group	10 Occluded fallopian tubes

Adverse Events

ESS505-A (Essure, BAY1454033)

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

ESS 305/ESS 505 (Essure, BAY1454032/Essure, BAY1454033)

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	ESS505-A (Essure, BAY1454033) n=31 participants at risk Bilateral hysteroscopic placement of the permanent birth control system, Model ESS505 insert with minimal polyethylene terephthalate (PET) fibers (investigational device model ESS505-A) followed by tubal occlusion evaluation by hysterosalpingogram (HSG) approximately 60 minutes following insert placement. A subsequent HSG was performed prior to the subjects' scheduled hysterectomy procedures at 30 (group 3), 60 (group 2) or 90 days (group 1) post insert placement.	ESS 305/ESS 505 (Essure, BAY1454032/Essure, BAY1454033) n=35 participants at risk Unilateral hysteroscopic placement of the permanent birth control system, Model ESS505 insert inclusive of polyethylene terephthalate (PET) fibers (investigational device model ESS505) and contralateral placement of the current commercially approved Essure device, model ESS305 followed by tubal occlusion evaluation by hysterosalpingogram (HSG) approximately 60 minutes following insert placement. A subsequent HSG was performed prior to the subjects' scheduled hysterectomy procedures at 30 (group 3), 60 (group 2) or 90 days (group 1) post insert placement. At the conclusion of the hysterectomy, the uterine cornua and fallopian tubes were sent to a pathology lab for histological preparation, and subsequent evaluation.
Gastrointestinal disorders Abdominal discomfort	0.00% 0/31 • Adverse event data were collected after signing the informed consent up to 90 days after insert placement. The reported adverse events cannot be localized to either intervention for women in receipt of ESS305/ESS505, therefore the observed adverse events were reported in a single arm.	5.7% 2/35 • Number of events 2 • Adverse event data were collected after signing the informed consent up to 90 days after insert placement. The reported adverse events cannot be localized to either intervention for women in receipt of ESS305/ESS505, therefore the observed adverse events were reported in a single arm.
Vascular disorders Hot flush	0.00% 0/31 • Adverse event data were collected after signing the informed consent up to 90 days after insert placement. The reported adverse events cannot be localized to either intervention for women in receipt of ESS305/ESS505, therefore the observed adverse events were reported in a single arm.	2.9% 1/35 • Number of events 1 • Adverse event data were collected after signing the informed consent up to 90 days after insert placement. The reported adverse events cannot be localized to either intervention for women in receipt of ESS305/ESS505, therefore the observed adverse events were reported in a single arm.
Reproductive system and breast disorders Vaginal laceration	0.00% 0/31 • Adverse event data were collected after signing the informed consent up to 90 days after insert placement. The reported adverse events cannot be localized to either intervention for women in receipt of ESS305/ESS505, therefore the observed adverse events were reported in a single arm.	2.9% 1/35 • Number of events 1 • Adverse event data were collected after signing the informed consent up to 90 days after insert placement. The reported adverse events cannot be localized to either intervention for women in receipt of ESS305/ESS505, therefore the observed adverse events were reported in a single arm.
General disorders Sensation of pressure	0.00% 0/31 • Adverse event data were collected after signing the informed consent up to 90 days after insert placement. The reported adverse events cannot be localized to either intervention for women in receipt of ESS305/ESS505, therefore the observed adverse events were reported in a single arm.	2.9% 1/35 • Number of events 1 • Adverse event data were collected after signing the informed consent up to 90 days after insert placement. The reported adverse events cannot be localized to either intervention for women in receipt of ESS305/ESS505, therefore the observed adverse events were reported in a single arm.
Blood and lymphatic system disorders Anemia	3.2% 1/31 • Number of events 1 • Adverse event data were collected after signing the informed consent up to 90 days after insert placement. The reported adverse events cannot be localized to either intervention for women in receipt of ESS305/ESS505, therefore the observed adverse events were reported in a single arm.	0.00% 0/35 • Adverse event data were collected after signing the informed consent up to 90 days after insert placement. The reported adverse events cannot be localized to either intervention for women in receipt of ESS305/ESS505, therefore the observed adverse events were reported in a single arm.
Cardiac disorders Bradycardia	3.2% 1/31 • Number of events 1 • Adverse event data were collected after signing the informed consent up to 90 days after insert placement. The reported adverse events cannot be localized to either intervention for women in receipt of ESS305/ESS505, therefore the observed adverse events were reported in a single arm.	0.00% 0/35 • Adverse event data were collected after signing the informed consent up to 90 days after insert placement. The reported adverse events cannot be localized to either intervention for women in receipt of ESS305/ESS505, therefore the observed adverse events were reported in a single arm.

Additional Information

Therapeutic Area Head

BAYER

Email: clinical-trials-contact@bayerhealthcare.com

Results disclosure agreements

• Principal investigator is a sponsor employee A PI may be requested to delay results communications up to 18 months following study conclusion or until a summary of all study results initiated by Sponsor (first publication) has been published. Following first publication embargo, sponsor may review results communications for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor may request a postponement of results communications not to exceed 180 days.
• Publication restrictions are in place

Restriction type: OTHER