European New Texture Implant Clinical Experience With Round Breast Implants

• Sponsor: Allergan (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01639742
• Collaborator: (none)
• Enrollment: 18
• Locations: 4
• Arm: 1
• Actual Duration (Months): 63.8
• Patients Per Site: 4.5
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

The purpose of this study is to obtain clinical experience with the use of new texture, round breast implants in bilateral primary breast augmentation.

Condition or Disease	Intervention/Treatment	Phase
Breast Augmentation	Device: New texture round breast implants	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 18 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: European New Texture Implant Clinical Experience With Round Breast Implants
• Actual Study Start Date: Jun 18, 2012
• Actual Primary Completion Date: Jan 30, 2013
• Actual Study Completion Date: Oct 12, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: All Participants All participants who had new texture round breast implants surgically implanted.	Device: New texture round breast implants; Breast implant surgery

Outcome Measures

Primary Outcome Measures

1. Investigator Overall Satisfaction With the Device Using a 5-Point Scale [3 months]

   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.

Secondary Outcome Measures

1. Subject Satisfaction With Breasts Using the BREAST-Q Questionnaire [6 months]

   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.

2. Investigator Evaluation of Whether the Implant is Palpably Distinguishable From the Tissue [6 months]

   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.

3. Percentage of Participants With Capsular Contracture Evaluated by Four-Grade Baker Scale [Interim analysis: 12 months]

   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.

4. Percentage of Participants With Local Complications [Interim analysis: 12 months]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Be willing to undergo bilateral breast augmentation with subglandular, submuscular, or biplanar placement of the breast implants by inframammary approach only

• Be a candidate for the device styles and sizes available in the study

Exclusion Criteria:

• Have tuberous breasts, congenital anomalies of the breast (e.g., Poland's Syndrome), or grade 3 ptosis

• Have undergone any previous breast surgery

• Have tissue covering determined inadequate or unsuitable by the surgeon

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Praxisklinik Siepe Friedrichstraße 57	Bonn		Germany	53111
2	Malteser Krankenhaus	Bonn		Germany	53123
3	Akademikliniken 10	Stockholm		Sweden	11542
4	Dolan Park Hospital	Birmingham		United Kingdom	B60 1LY

Sponsors and Collaborators

• Allergan

Investigators

• Study Director: Per Heden, Allergan

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Allergan
• ClinicalTrials.gov Identifier: NCT01639742
• Other Study ID Numbers: ENTICE-001
• First Posted: Jul 13, 2012
• Last Update Posted: Nov 30, 2017
• Last Verified: Oct 1, 2017

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

Participant Flow

Arm/Group Title	All Participants
Arm/Group Description	All participants who had new texture round breast implants surgically implanted.
Period Title: Overall Study
STARTED	18
COMPLETED	0
NOT COMPLETED	18

Baseline Characteristics

Arm/Group Title	All Participants
Arm/Group Description	All participants who had new texture round breast implants surgically implanted.
Overall Participants	18
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	31.9 (8.89)
Sex: Female, Male (Count of Participants)
Female	18 100%
Male	0 0%

Outcome Measures

1. Primary Outcome

Title	Investigator Overall Satisfaction With the Device Using a 5-Point Scale
Description	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.
Time Frame	3 months

Outcome Measure Data

Analysis Population Description

Full analysis population included all participants.

Arm/Group Title	All Participants
Arm/Group Description	All participants who had new texture round breast implants surgically implanted.
Measure Participants	18
Mean (Standard Deviation) [score on a scale]	4.6 (0.62)

2. Secondary Outcome

Title	Subject Satisfaction With Breasts Using the BREAST-Q Questionnaire
Description	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.
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

Full analysis population included all participants.

Arm/Group Title	All Participants
Arm/Group Description	All participants who had new texture round breast implants surgically implanted.
Measure Participants	18
Mean (Standard Deviation) [score on a scale]	89.3 (11.69)

3. Secondary Outcome

Title	Investigator Evaluation of Whether the Implant is Palpably Distinguishable From the Tissue
Description	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.
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

Full analysis population included all participants.

Arm/Group Title	All Participants
Arm/Group Description	All participants who had new texture round breast implants surgically implanted.
Measure Participants	18
Mean (Standard Deviation) [score on a scale]	2.7 (0.96)

4. Secondary Outcome

Title	Percentage of Participants With Capsular Contracture Evaluated by Four-Grade Baker Scale
Description	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.
Time Frame	Interim analysis: 12 months

Outcome Measure Data

Analysis Population Description

Full analysis population included all participants.

Arm/Group Title	All Participants
Arm/Group Description	All participants who had new texture round breast implants surgically implanted.
Measure Participants	18
Baker Grade I	88.9 493.9%
Baker Grade II	11.1 61.7%
Baker Grade III	0.0 0%
Baker Grade IV	0.0 0%

5. Secondary Outcome

Title	Percentage of Participants With Local Complications
Description	The percentage of participants experiencing local complications (in the area of the implant) is reported.
Time Frame	Interim analysis: 12 months

Outcome Measure Data

Analysis Population Description

Full analysis population included all participants.

Arm/Group Title	All Participants
Arm/Group Description	All participants who had new texture round breast implants surgically implanted.
Measure Participants	18
Breast mass, cyst, lump	16.7 92.8%
Breast pain	100.0 555.6%
Implant malposition	11.1 61.7%
Swelling	11.1 61.7%
Other: Epitheliolysis	5.6 31.1%

Adverse Events

Arm/Group Title	All Participants
Arm/Group Description	All participants who had new texture round breast implants surgically implanted.
All Cause Mortality
	All Participants
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	All Participants
	Affected / at Risk (%)	# Events
Total	2/18 (11.1%)
General disorders
Device dislocation	2/18 (11.1%)
Other (Not Including Serious) Adverse Events
	All Participants
	Affected / at Risk (%)	# Events
Total	18/18 (100%)
Cardiac disorders
Bradycardia	1/18 (5.6%)
Gastrointestinal disorders
Nausea	1/18 (5.6%)
General disorders
Breast complication associated with device	1/18 (5.6%)
Infections and infestations
Genitourinary tract infection	1/18 (5.6%)
Pneumonia	1/18 (5.6%)
Urinary tract infection	1/18 (5.6%)
Vulvovaginal mycotic infection	1/18 (5.6%)
Injury, poisoning and procedural complications
Post procedural complication	2/18 (11.1%)
Post procedural swelling	1/18 (5.6%)
Procedural dizziness	1/18 (5.6%)
Procedural headache	1/18 (5.6%)
Procedural pain	18/18 (100%)
Musculoskeletal and connective tissue disorders
Back pain	1/18 (5.6%)
Neck pain	1/18 (5.6%)
Tenosynovitis	1/18 (5.6%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign breast neoplasm	1/18 (5.6%)
Nervous system disorders
Dizziness	1/18 (5.6%)
Hypoaesthesia	1/18 (5.6%)
Psychiatric disorders
Depression	1/18 (5.6%)
Reproductive system and breast disorders
Breast cyst	2/18 (11.1%)
Breast pain	1/18 (5.6%)
Skin and subcutaneous tissue disorders
Drug eruption	1/18 (5.6%)
Erythema	1/18 (5.6%)
Vascular disorders
Phlebitis superficial	1/18 (5.6%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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.