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This is an open-label, prospective, uncontrolled, single arm, post-marketing study of the long-term safety and performance of EARFOLD® Implantable Clip System.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EARFOLD® | Experimental | EARFOLD® implant is inserted subcutaneously using the sterile disposable EARFOLD® introducer under local anaesthetic |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EARFOLD® | Device | EARFOLD® implant is inserted subcutaneously using the sterile disposable EARFOLD® introducer under local anaesthetic |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline pre-insertion in EAR-Q Ears Appearance Questionnaire score | EAR-Q Ears Appearance Questionnaire is on a 4 point scale (1=Not at all, 2=A little bit, 3=Quite a bit, 4=Very much) | Baseline to month 3 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline pre-insertion in EAR-Q Ears Appearance overall score at 12 months post-implantation | EAR-Q Ears Appearance Questionnaire is on a 4 point scale (1=Not at all, 2=A little bit, 3=Quite a bit, 4=Very much) | Baseline to Month 12 |
| Change from baseline pre-insertion in EAR-Q Ears Appearance overall score at 24 months post-implantation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| ALLERGAN INC. | Allergan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital of Derby and Burton NHS Foundation Trust /ID# 233610 | Derby | Derbyshire | DE22 3NE | United Kingdom | ||
AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
For details on when studies are available for sharing, please refer to the link below
Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Use Agreement (DUA). For more information on the process, or to submit a request, visit the following link.
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EAR-Q Ears Appearance Questionnaire is on a 4 point scale (1=Not at all, 2=A little bit, 3=Quite a bit, 4=Very much) |
| Baseline to Month 24 |
| Percentage of patients that require re-operation at any moment | Percentage of patients that require re-operation at any moment during the investigational period | 24 months |
| Percentage of patients with recurrence of ear prominence | Percentage of patients with recurrence of ear prominence at any moment during the investigational period | 24 months |
| Change from baseline of Short Form-12 score at Month 3 for subjects over 18 years | The Short Form-12 Health Survey will be administered to subjects over 18 years old to measure health and well-being | Baseline to Month 3 |
| Change from baseline of Short Form-12 score at Month 12 for subjects over 18 years | The Short Form-12 Health Survey will be administered to subjects over 18 years old to measure health and well-being | Baseline to Month 12 |
| Change from baseline of Short Form-12 score at Month 24 for subjects over 18 years | The Short Form-12 Health Survey will be administered to subjects over 18 years old to measure health and well-being | Baseline to Month 24 |
| Change from baseline of Short Form-10 score at Month 3 for subjects under 18 years old | The Short Form-10 Health Survey will be administered to subjects under 18 years old to measure health and well-being | Baseline to Month 3 |
| Change from baseline of Short Form-10 score at Month 12 for subjects under 18 years old | The Short Form-10 Health Survey will be administered to subjects under 18 years old to measure health and well-being | Baseline to Month 12 |
| Change from baseline of Short Form-10 score at Month 24 for subjects under 18 years old | The Short Form-10 Health Survey will be administered to subjects under 18 years old to measure health and well-being | Baseline to Month 24 |
| Change from baseline in maximum helix to scalp distance from before PREFOLD® insertion at Month 3 | Helix to scalp distance with untreated ears compared to EARFOLD in | Baseline to Month 3 |
| Change from baseline in maximum helix to scalp distance from before PREFOLD® insertion at Month 12 | Helix to scalp distance with untreated ears compared to EARFOLD in | Baseline to Month 12 |
| Change from baseline in maximum helix to scalp distance from before PREFOLD® insertion at Month 24 | Helix to scalp distance with untreated ears compared to EARFOLD in | Baseline to Month 24 |
| Maintenance of maximum helix to scalp distance at 12 months compared to 3 months visit post insertion of EARFOLD | Helix to scalp distance with EARFOLD inserted | Month 3 to Month 12 |
| Maintenance of maximum helix to scalp distance at 24 months compared to 3 months visit post insertion of EARFOLD | Helix to scalp distance with EARFOLD inserted | Month 3 to Month 24 |
| Change in maximum helix to scalp distance from PREFOLD® insertion to post insertion distances at Month 3 | Helix to scalp distance with PREFOLD® in compared with EARFOLD in | Baseline to Month 3 |
| Change in maximum helix to scalp distance from PREFOLD® insertion to post insertion distances at Month 12 | Helix to scalp distance with PREFOLD® in compared with EARFOLD in | Baseline to Month 12 |
| Change in maximum helix to scalp distance from PREFOLD® insertion to post insertion distances at Month 24 | Helix to scalp distance with PREFOLD® in compared with EARFOLD in | Baseline to Month 24 |
| Duration of EARFOLD® insertion procedure | From the first incision of the scalpel to the last application of the sterristrip over the wound, duration of surgery | Duration of surgery |
| Change from baseline pre-insertion in EAR-Q Social Function Questionnaire at Month 3 | EAR-Q Social Function Questionnaire is on a 4 point scale (1=Never, 2=Sometimes, 3=Often, 4=Always) | Baseline to Month 3 |
| Change from baseline pre-insertion in EAR-Q Social Function Questionnaire at Month 12 | EAR-Q Social Function Questionnaire is on a 4 point scale (1=Never, 2=Sometimes, 3=Often, 4=Always) | Baseline to Month 12 |
| Change from baseline pre-insertion in EAR-Q Social Function Questionnaire at Month 24 | EAR-Q Social Function Questionnaire is on a 4 point scale (1=Never, 2=Sometimes, 3=Often, 4=Always) | Baseline to Month 24 |
| Change from baseline pre-insertion in EAR-Q School Function Questionnaire at Month 3 | EAR-Q School Function Questionnaire is on a 4 point scale (1=Never, 2=Sometimes, 3=Often, 4=Always) | Baseline to Month 3 |
| Change from baseline pre-insertion in EAR-Q School Function Questionnaire at Month 12 | EAR-Q School Function Questionnaire is on a 4 point scale (1=Never, 2=Sometimes, 3=Often, 4=Always) | Baseline to Month 12 |
| Change from baseline pre-insertion in EAR-Q School Function Questionnaire at Month 24 | EAR-Q School Function Questionnaire is on a 4 point scale (1=Never, 2=Sometimes, 3=Often, 4=Always) | Baseline to Month 24 |
| Change from baseline pre-insertion in EAR-Q Psychological Function Questionnaire at Month 3 | EAR-Q Psychological Function Questionnaire is on a 4 point scale (1=Never, 2=Sometimes, 3=Often, 4=Always) | Baseline to Month 3 |
| Change from baseline pre-insertion in EAR-Q Psychological Function Questionnaire at Month 12 | EAR-Q Psychological Function Questionnaire is on a 4 point scale (1=Never, 2=Sometimes, 3=Often, 4=Always) | Baseline to Month 12 |
| Change from baseline pre-insertion in EAR-Q Psychological Function Questionnaire at Month 24 | EAR-Q Psychological Function Questionnaire is on a 4 point scale (1=Never, 2=Sometimes, 3=Often, 4=Always) | Baseline to Month 24 |
| Return to normal activities questionnaire after EARFOLD® surgery at Month 3 | Return to normal activities questionnaire is on a 11-point scale ranging from 10=strongly agree to 0=strongly disagree | Month 3 |
| The Royal Free London NHS Foundation Trust /ID# 233617 |
| London |
| London, City of |
| NW3 2QG |
| United Kingdom |
| La Belle Forme /ID# 233664 | Glasgow | G1 1SS | United Kingdom |
| Sthetix /ID# 233668 | Liverpool | L1 9DS | United Kingdom |
| Medcentres Plus /ID# 233687 | Salisbury | SP1 3SL | United Kingdom |
| AL Aesthetics /ID# 233672 | Wolvehampton | WV6 0BW | United Kingdom |