Trial Outcomes & Findings for European New Texture Implant Clinical Experience With Shaped Breast Implants (NCT NCT01639755)

Results Overview

The investigator evaluated the overall satisfaction with the device using a 5-point scale where 1=definitely dissatisfied with the device to 5=definitely satisfied with the device.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

19 participants

Primary outcome timeframe

3 months

Results posted on

2017-11-30

Participant Flow

Participant milestones

Participant milestones
Measure	All Participants Al participants who had new texture shaped breast implants surgically implanted.
Overall Study STARTED	19
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	19

Reasons for withdrawal

Reasons for withdrawal
Measure	All Participants Al participants who had new texture shaped breast implants surgically implanted.
Overall Study Study Ongoing	15
Overall Study Patient had device explantation	4

Baseline Characteristics

European New Texture Implant Clinical Experience With Shaped Breast Implants

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Participants n=19 Participants Al participants who had new texture shaped breast implants surgically implanted.
Age, Continuous	29.3 years STANDARD_DEVIATION 9.57 • n=5 Participants
Sex: Female, Male Female	19 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 3 months

Population: Full analysis population included all participants.

The investigator evaluated the overall satisfaction with the device using a 5-point scale where 1=definitely dissatisfied with the device to 5=definitely satisfied with the device.

Outcome measures

Outcome measures
Measure	All Participants n=19 Participants Al participants who had new texture shaped breast implants surgically implanted.
Investigator Overall Satisfaction With the Device Using a 5-Point Scale	4.6 score on a scale Standard Deviation 0.77

SECONDARY outcome

Timeframe: 6 months

Population: Full analysis population included all participants.

Participants evaluated satisfaction with their breasts using the BREAST-Q. Summary scores were computed by summing the score of each response and transferring them to a 0 (worst) to 100 (best) scale.

Outcome measures

Outcome measures
Measure	All Participants n=19 Participants Al participants who had new texture shaped breast implants surgically implanted.
Subject Satisfaction With Breasts Using the BREAST-Q Questionnaire	87.1 score on a scale Standard Deviation 16.95

SECONDARY outcome

Timeframe: 6 months

Population: Full analysis population included all participants.

The investigator examined the breasts and evaluated whether the implant was palpably distinguishable from the tissue using a 5-point scale where 1=implant very easy to distinguish from the tissue to 5=implant indistinguishable from the tissue.

Outcome measures

Outcome measures
Measure	All Participants n=19 Participants Al participants who had new texture shaped breast implants surgically implanted.
Investigator Evaluation of Whether the Implant is Palpably Distinguishable From the Tissue	2.5 score on a scale Standard Deviation 0.77

SECONDARY outcome

Timeframe: Interim analysis: 12 months

Population: Participants from the Full Analysis population with data available for analysis.

The investigator evaluated capsular contracture (lining of cells formed around the device as the body's response to a foreign object) using the Four-Grade Baker scale where: Grade I= Breast is normally soft and looks natural, Grade II= Breast is a little firm but looks normal, Grade III=Breast is firm and looks abnormal or Grade IV= Breast is hard, painful, and looks abnormal. The percentage of participants in each Baker Grade is reported.

Outcome measures

Outcome measures
Measure	All Participants n=18 Participants Al participants who had new texture shaped breast implants surgically implanted.
Percentage of Participants With Capsular Contracture Evaluated by Four-Grade Baker Scale Baker Grade I	88.9 percentage of participants
Percentage of Participants With Capsular Contracture Evaluated by Four-Grade Baker Scale Baker Grade II	11.1 percentage of participants
Percentage of Participants With Capsular Contracture Evaluated by Four-Grade Baker Scale Baker Grade III	0.0 percentage of participants
Percentage of Participants With Capsular Contracture Evaluated by Four-Grade Baker Scale Baker Grade IV	0.0 percentage of participants

SECONDARY outcome

Timeframe: Interim analysis: 12 months

Population: Full analysis population included all participants.

The percentage of participants experiencing local complications (in the area of the implant) is reported.

Outcome measures

Outcome measures
Measure	All Participants n=19 Participants Al participants who had new texture shaped breast implants surgically implanted.
Percentage of Participants With Local Complications Breast pain	100.0 percentage of participants
Percentage of Participants With Local Complications Implant malposition	15.8 percentage of participants

Adverse Events

All Participants

Serious events: 2 serious events

Other events: 19 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	All Participants n=19 participants at risk Al participants who had new texture shaped breast implants surgically implanted.
General disorders Device dislocation	10.5% 2/19
Psychiatric disorders Anxiety	5.3% 1/19

Other adverse events

Other adverse events
Measure	All Participants n=19 participants at risk Al participants who had new texture shaped breast implants surgically implanted.
Gastrointestinal disorders Abdominal pain	5.3% 1/19
Gastrointestinal disorders Constipation	5.3% 1/19
General disorders Breast complication associated with device	5.3% 1/19
Infections and infestations Helicobacter gastritis	5.3% 1/19
Infections and infestations Urinary tract infection	5.3% 1/19
Injury, poisoning and procedural complications Post procedural oedema	5.3% 1/19
Injury, poisoning and procedural complications Postoperative fever	5.3% 1/19
Injury, poisoning and procedural complications Procedural pain	100.0% 19/19
Nervous system disorders Nervous system disorder	5.3% 1/19
Reproductive system and breast disorders Breast pain	5.3% 1/19
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	5.3% 1/19
Psychiatric disorders Anxiety	5.3% 1/19

Additional Information

Therapeutic Area Head,

Allergan, Inc

Phone: 714-246-4500

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
Publication restrictions are in place

Restriction type: OTHER