Retrospective Data Collection on the Use of Motiva Flora TE in Breast Reconstruction

• Sponsor: Establishment Labs (Industry)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05459064
• Collaborator: (none)
• Enrollment: 120
• Anticipated Duration (Months): 4

Study Details

Study Description

Brief Summary

The Motiva Flora® TE are intended for temporary subcutaneous or submuscular implantation to develop surgical flaps and additional tissue coverage and are not intended for use beyond six (6) months.

All Motiva Flora® TE's require periodic, incremental inflation with sterile saline for injection until the desired tissue amount is developed. After the desired volume, the expander is surgically removed and replaced with a long-term breast implant in the same space as the tissue expander.

The study collects retrospective data on the use of the Motiva Flora TE, from patients who had a tissue expander-based-breast reconstruction using the Motiva Flora® TE since market introduction in May 2020.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer	Device: Motiva Flora TE

Study Design

• Study Type: Observational
• Anticipated Enrollment: 120 participants
• Observational Model: Other
• Time Perspective: Retrospective
• Official Title: Retrospective Data Collection on the Use of Motiva Flora TE in Breast Reconstruction
• Anticipated Study Start Date: Jul 1, 2022
• Anticipated Primary Completion Date: Sep 1, 2022
• Anticipated Study Completion Date: Nov 1, 2022

Outcome Measures

Primary Outcome Measures

1. Safety - adverse events [Until finalization of staged Breast reconstruction, approximately 6 months]

   Cumulative incidence and causal relationship with the device of adverse events (AEs) reported by the surgeon. This includes known complications as listed in the IFU, as well as any other adverse events, seen as at least possibly related to the device according to the surgeon.

2. Safety - device deficiencies [Until finalization of staged Breast reconstruction, approximately 6 months]

   Device-related complications include those resulting from any device failure, including those resulting in removal and/or replacement of the Motiva Flora® TE.

3. Performance - succesful implant of long-term breast implant [Until finalization of staged Breast reconstruction, approximately 6 months]

   Successful tissue expander-based-breast reconstruction is measured by the fact that the second step of the staged procedure - the implantation of the long-term breast implant - could be performed or not as initially planned, as per surgeon judgement (Yes / No)

4. Performance - surgeon satisfaction [Until finalization of staged Breast reconstruction, approximately 6 months]

   Surgeon's overall satisfaction with the results of the expansion according to the General Aesthetic Improvement Scale (GAIS), a 5-point Likert scale (1=very significant improvement, 2=significant improvement, 3=improvement, 4=no change and 5=decline) after the completion of the breast reconstruction (after the second surgery (long-term breast implant).

Secondary Outcome Measures

1. Length of hospitalization [Until discharge from hospital after first surgery (Motiva Flora Tissue Expander), approximately 1-2 days]

   Length of hospitalization is measured in number of days that the patient stays in hospital after surgery, starting from the day after surgery.

2. Surgical difficulties- 1st surgery (Motiva Flora TE implantation) [Intraoperative]

   Possible difficulties during the during the 1st surgery, measured through the occurrence of: device deficiencies / malfunctions difficulties filling the Tissue expander with the Port Locator

3. Surgical difficulties - 2nd surgery (Long-term breast implant) [Intraoperative]

   Possible difficulties during the 2nd surgery, measured through the occurrence of: o device deficiencies /malfunctions

4. Concomitant treatments - 1st surgery [Intraoperative]

   Concomitant treatments during the 1st surgery is measured through the occurrence of: Lipotransfer Latissimus Dorsi Flap

5. Concomitant treatments - 2nd surgery [Intraoperative]

   Concomitant treatments during the 2nd surgery is measured through the: Use of Motiva Sizers The occurrence of Lipotransfer

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patient has completed a tissue expander-based breast reconstruction with the Motiva Flora® TE .

• Patient has been informed correctly according to to the applicable national and local regulations.

Exclusion Criteria:

• Not applicable

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Establishment Labs

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Establishment Labs
• ClinicalTrials.gov Identifier: NCT05459064
• Other Study ID Numbers: CLINP-001013
• First Posted: Jul 14, 2022
• Last Update Posted: Jul 14, 2022
• Last Verified: Jul 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Jul 14, 2022