Trial Outcomes & Findings for European New Texture Implant Clinical Experience With Round Breast Implants (NCT NCT01639742)

NCT ID: NCT01639742

Last Updated: 2017-11-30

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

NA

Target enrollment

18 participants

Primary outcome timeframe

3 months

Results posted on

2017-11-30

Participant Flow

Participant milestones

Participant milestones
Measure	All Participants All participants who had new texture round breast implants surgically implanted.
Overall Study STARTED	18
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	18

Reasons for withdrawal

Reasons for withdrawal
Measure	All Participants All participants who had new texture round breast implants surgically implanted.
Overall Study Study Ongoing	17
Overall Study Lost to Follow-up	1

Baseline Characteristics

European New Texture Implant Clinical Experience With Round Breast Implants

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Participants n=18 Participants All participants who had new texture round breast implants surgically implanted.
Age, Continuous	31.9 years STANDARD_DEVIATION 8.89 • n=5 Participants
Sex: Female, Male Female	18 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=18 Participants All participants who had new texture round breast implants surgically implanted.
Investigator Overall Satisfaction With the Device Using a 5-Point Scale	4.6 score on a scale Standard Deviation 0.62 • Interval 4.3 to 4.9

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=18 Participants All participants who had new texture round breast implants surgically implanted.
Subject Satisfaction With Breasts Using the BREAST-Q Questionnaire	89.3 score on a scale Standard Deviation 11.69

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=18 Participants All participants who had new texture round breast implants surgically implanted.
Investigator Evaluation of Whether the Implant is Palpably Distinguishable From the Tissue	2.7 score on a scale Standard Deviation 0.96

SECONDARY outcome

Timeframe: Interim analysis: 12 months

Population: Full analysis population included all participants.

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 All participants who had new texture round 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=18 Participants All participants who had new texture round breast implants surgically implanted.
Percentage of Participants With Local Complications Breast mass, cyst, lump	16.7 percentage of participants
Percentage of Participants With Local Complications Breast pain	100.0 percentage of participants
Percentage of Participants With Local Complications Implant malposition	11.1 percentage of participants
Percentage of Participants With Local Complications Swelling	11.1 percentage of participants
Percentage of Participants With Local Complications Other: Epitheliolysis	5.6 percentage of participants

Adverse Events

All Participants

Serious events: 2 serious events

Other events: 18 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	All Participants n=18 participants at risk All participants who had new texture round breast implants surgically implanted.
General disorders Device dislocation	11.1% 2/18

Other adverse events

Other adverse events
Measure	All Participants n=18 participants at risk All participants who had new texture round breast implants surgically implanted.
Cardiac disorders Bradycardia	5.6% 1/18
Gastrointestinal disorders Nausea	5.6% 1/18
General disorders Breast complication associated with device	5.6% 1/18
Infections and infestations Genitourinary tract infection	5.6% 1/18
Infections and infestations Pneumonia	5.6% 1/18
Infections and infestations Urinary tract infection	5.6% 1/18
Infections and infestations Vulvovaginal mycotic infection	5.6% 1/18
Injury, poisoning and procedural complications Post procedural complication	11.1% 2/18
Injury, poisoning and procedural complications Post procedural swelling	5.6% 1/18
Injury, poisoning and procedural complications Procedural dizziness	5.6% 1/18
Injury, poisoning and procedural complications Procedural headache	5.6% 1/18
Injury, poisoning and procedural complications Procedural pain	100.0% 18/18
Musculoskeletal and connective tissue disorders Back pain	5.6% 1/18
Musculoskeletal and connective tissue disorders Neck pain	5.6% 1/18
Musculoskeletal and connective tissue disorders Tenosynovitis	5.6% 1/18
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign breast neoplasm	5.6% 1/18
Nervous system disorders Dizziness	5.6% 1/18
Nervous system disorders Hypoaesthesia	5.6% 1/18
Psychiatric disorders Depression	5.6% 1/18
Reproductive system and breast disorders Breast cyst	11.1% 2/18
Reproductive system and breast disorders Breast pain	5.6% 1/18
Skin and subcutaneous tissue disorders Drug eruption	5.6% 1/18
Skin and subcutaneous tissue disorders Erythema	5.6% 1/18
Vascular disorders Phlebitis superficial	5.6% 1/18

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