Trial Outcomes & Findings for A 7-year Follow up of All Subjects Incuded in Protocol 31GB0106 (NCT NCT01146275)

Results Overview

The MRI investigation was performed to evaluate if the subjects has study product (Macrolane-a Hyaluronic acid) in their breast 7 years after the treatment.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

6 participants

Primary outcome timeframe

7 years +/- 6months post treatment

Results posted on

2022-09-28

Participant Flow

Participant milestones

Participant milestones
Measure	Participants in the Pilot Study 31GB0601 This is an additional safety follow up 7-years post treatment, for subjects enroled in a pilot study using a previous formulation of Macrolane for breast augmentation. Radiologial breast examination : MRI of breast, mammograophy and ultrasound of breast
Overall Study STARTED	6
Overall Study COMPLETED	6
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A 7-year Follow up of All Subjects Incuded in Protocol 31GB0106

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Participants in the Pilot Study 31GB0601 n=6 Participants This is an additional safety follow up 7-years post treatment, for subjects enroled in a pilot study using a previous formulation of Macrolane for breast augmentation. Radiologial breast examination : MRI of breast, mammograophy and ultrasound of breast
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	6 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	31 years STANDARD_DEVIATION 4.3 • n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Region of Enrollment Sweden	6 participants n=5 Participants

PRIMARY outcome

Timeframe: 7 years +/- 6months post treatment

Population: MRI were performed by 4 women out of 6. One woman was pregnant and therefore not included and one did not want to perform MRI.

The MRI investigation was performed to evaluate if the subjects has study product (Macrolane-a Hyaluronic acid) in their breast 7 years after the treatment.

Outcome measures

Outcome measures
Measure	Participants in the Pilot Study 31GB0601 n=4 Participants This is an additional safety follow up 7-years post treatment, for subjects enrolled in a pilot study using a previous formulation of Macrolane (Hyaluronic acid) for breast augmentation. Radiologial breast examination : MRI of breast, mammography and ultrasound of breast The MRI investigation was performed to evaluate if the subjects has study product (Macrolane-a Hyaluronic acid) in their breast 7 years after the treatment.
To Evaluate if the Subject Has Macrolane Deposits in the Breast Seven Years Post Treatment, Using a Comprehensive MRI Investigation	4 participants with remaining product

PRIMARY outcome

Timeframe: 7 years +/- 6 months post treatment

Population: Subjects that participated in study 31GB0106 was asked to partícipate in the study 31GB0904. 6 subjects signed Informed consent for this study.

To evaluate the long term safety of Macrolane in breast enhancement, using relevant medical history, breast examination, mammography and ultrasound as well as a comprehensive MRI investigation. Participants with AE/SAE since participation in study 31GB0106 or any findings at the breast examination, mammography, ultrasound or comprehensive MRI investigation

Outcome measures

Outcome measures
Measure	Participants in the Pilot Study 31GB0601 n=6 Participants This is an additional safety follow up 7-years post treatment, for subjects enrolled in a pilot study using a previous formulation of Macrolane (Hyaluronic acid) for breast augmentation. Radiologial breast examination : MRI of breast, mammography and ultrasound of breast The MRI investigation was performed to evaluate if the subjects has study product (Macrolane-a Hyaluronic acid) in their breast 7 years after the treatment.
To Evaluate the Long Term Safety of Macrolane in Breast Enhancement	0 participants

Adverse Events

Participants in the Pilot Study 31GB0601

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Head of Medical Affairs

Q-Med AB

Phone: +46 (0) 18 4749000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60