Trial Outcomes & Findings for Evaluation of the Cook Biodesign® Nipple Reconstruction Cylinder (NRC) (NCT NCT01216319)

NCT ID: NCT01216319

Last Updated: 2016-06-23

Results Overview

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 50 participants
• Primary outcome timeframe: 12 months
• Results posted on: 2016-06-23

Participant Flow

Participant milestones

Measure	Nipple Reconstruction Cylinder Nipple reconstruction: Biodesign® Nipple Reconstruction Cylinder
Overall Study STARTED	50
Overall Study COMPLETED	46
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Measure	Nipple Reconstruction Cylinder Nipple reconstruction: Biodesign® Nipple Reconstruction Cylinder
Overall Study Lost to Follow-up	2
Overall Study Unanticipated chemo for breast cancer	2

Baseline Characteristics

Evaluation of the Cook Biodesign® Nipple Reconstruction Cylinder (NRC)

Baseline characteristics by cohort

Measure	Nipple Reconstruction Cylinder n=50 Participants Nipple reconstruction: Biodesign® Nipple Reconstruction Cylinder
Age, Continuous	52 years STANDARD_DEVIATION 8.7 • n=5 Participants
Sex: Female, Male Female	50 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 12 months

Population: There were two patients (three nipples) without plastic surgery matrix in place at 12MO.

Outcome measures

Measure	Nipple Reconstruction Cylinder n=72 Nipples Nipple reconstruction: Biodesign® Nipple Reconstruction Cylinder
Percent Nipple Projection at 12 Months Compared to Baseline (1 Week Post-procedure)	37.3 percentage of projection vs baseline Standard Deviation 17.5

SECONDARY outcome

Timeframe: 12 months

Patient satisfaction is defined as patient would recommend the nipple reconstruction operation to others.

Outcome measures

Measure	Nipple Reconstruction Cylinder n=46 Participants Nipple reconstruction: Biodesign® Nipple Reconstruction Cylinder
Rate of Patient Satisfaction	97.8 percentage of patients

Adverse Events

Nipple Reconstruction Cylinder

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Measure	Nipple Reconstruction Cylinder n=50 participants at risk Nipple reconstruction: Biodesign® Nipple Reconstruction Cylinder
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic breast cancer	2.0% 1/50 • Number of events 1

Other adverse events

Measure	Nipple Reconstruction Cylinder n=50 participants at risk Nipple reconstruction: Biodesign® Nipple Reconstruction Cylinder
Surgical and medical procedures Cylinder extrusion	6.0% 3/50 • Number of events 4

Additional Information

Jason Hodde, Clinical Affairs Manager

Cook Biotech Incorporated

Phone: 765-497-3355

Email: jhodde@cookbiotech.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: GT60