Trial Outcomes & Findings for Feasibility Study of the Magnetic Anal Sphincter (FENIX System) (NCT NCT01625221)

Last Updated: 2018-01-03

Results Overview

The safety objective will be met via reporting all adverse events at various time points including implant, 6 weeks, 3 months, 6 months, and 12 months (and then semi-annually until 5 years post-implant at U.S. sites). Serious device- and procedure-related adverse events will be summarized separately. Safety will be characterized by physical examination and pelvic X-ray evaluations.

Recruitment status

COMPLETED

Study phase

Target enrollment

35 participants

Primary outcome timeframe

60 months

Results posted on

2018-01-03

Participant Flow

Participant milestones

Participant milestones
Measure	Magnetic Anal Sphincter Augmentation The implantable single-use Magnetic Anal Sphincter (FENIX) device consists of a series of titanium beads with magnetic cores that are linked together with independent titanium wires forming an annular shape. The device is supplied sterile and is placed through an open incision. Magnetic Anal Sphincter: The implantable single-use Magnetic Anal Sphincter (FENIX) device consists of a series of titanium beads with magnetic cores that are linked together with independent titanium wires forming an annular shape. The device is supplied sterile and is placed through an open incision.
Overall Study STARTED	35
Overall Study COMPLETED	28
Overall Study NOT COMPLETED	7

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Feasibility Study of the Magnetic Anal Sphincter (FENIX System)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Magnetic Anal Sphincter Augmentation n=35 Participants The implantable single-use Magnetic Anal Sphincter (FENIX) device consists of a series of titanium beads with magnetic cores that are linked together with independent titanium wires forming an annular shape. The device is supplied sterile and is placed through an open incision. Magnetic Anal Sphincter: The implantable single-use Magnetic Anal Sphincter (FENIX) device consists of a series of titanium beads with magnetic cores that are linked together with independent titanium wires forming an annular shape. The device is supplied sterile and is placed through an open incision.
Age, Continuous	64.1 years STANDARD_DEVIATION 9.7 • n=5 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	18 Participants n=5 Participants
Age, Categorical >=65 years	17 Participants n=5 Participants
Sex: Female, Male Female	34 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants
Region of Enrollment France	15 participants n=5 Participants
Region of Enrollment United States	15 participants n=5 Participants
Region of Enrollment Denmark	5 participants n=5 Participants
Fecal incontinence episodes	13.9 episodes per week STANDARD_DEVIATION 6.7 • n=5 Participants

PRIMARY outcome

Timeframe: 60 months

Population: All adverse events as reported by investigators

Outcome measures

Outcome measures
Measure	Magnetic Anal Sphincter Augmentation n=35 Participants The implantable single-use Magnetic Anal Sphincter (FENIX) device consists of a series of titanium beads with magnetic cores that are linked together with independent titanium wires forming an annular shape. The device is supplied sterile and is placed through an open incision. Magnetic Anal Sphincter: The implantable single-use Magnetic Anal Sphincter (FENIX) device consists of a series of titanium beads with magnetic cores that are linked together with independent titanium wires forming an annular shape. The device is supplied sterile and is placed through an open incision.
Adverse Events All Adverse Events	223 Number of events
Adverse Events Serious Device or Procedure-related Adverse Events	7 Number of events

PRIMARY outcome

Timeframe: 12 Months

Effectiveness will be characterized as the reduction of FI symptoms by subjective measurements using the FISI, Wexner, and FIQOL scores and a three week diary documenting episodes of incontinence.

Outcome measures

Outcome measures
Measure	Magnetic Anal Sphincter Augmentation n=28 Participants The implantable single-use Magnetic Anal Sphincter (FENIX) device consists of a series of titanium beads with magnetic cores that are linked together with independent titanium wires forming an annular shape. The device is supplied sterile and is placed through an open incision. Magnetic Anal Sphincter: The implantable single-use Magnetic Anal Sphincter (FENIX) device consists of a series of titanium beads with magnetic cores that are linked together with independent titanium wires forming an annular shape. The device is supplied sterile and is placed through an open incision.
Reduction in Fecal Incontinence Symptoms	3.8 episodes per week Standard Deviation 5.1

Adverse Events

Magnetic Anal Sphincter Augmentation

Serious events: 6 serious events

Other events: 12 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Magnetic Anal Sphincter Augmentation n=35 participants at risk The implantable single-use Magnetic Anal Sphincter (FENIX) device consists of a series of titanium beads with magnetic cores that are linked together with independent titanium wires forming an annular shape. The device is supplied sterile and is placed through an open incision. Magnetic Anal Sphincter: The implantable single-use Magnetic Anal Sphincter (FENIX) device consists of a series of titanium beads with magnetic cores that are linked together with independent titanium wires forming an annular shape. The device is supplied sterile and is placed through an open incision.
Infections and infestations Infection	11.4% 4/35
Skin and subcutaneous tissue disorders Device erosion	2.9% 1/35
Gastrointestinal disorders Impaction or defecatory disorder	2.9% 1/35
Immune system disorders Allergy, inflammation reaction	2.9% 1/35

Other adverse events

Other adverse events
Measure	Magnetic Anal Sphincter Augmentation n=35 participants at risk The implantable single-use Magnetic Anal Sphincter (FENIX) device consists of a series of titanium beads with magnetic cores that are linked together with independent titanium wires forming an annular shape. The device is supplied sterile and is placed through an open incision. Magnetic Anal Sphincter: The implantable single-use Magnetic Anal Sphincter (FENIX) device consists of a series of titanium beads with magnetic cores that are linked together with independent titanium wires forming an annular shape. The device is supplied sterile and is placed through an open incision.
Skin and subcutaneous tissue disorders Device erosion	8.6% 3/35
Gastrointestinal disorders Pain	17.1% 6/35
Gastrointestinal disorders Impaction or defecatory disorder	5.7% 2/35
Gastrointestinal disorders Rectal bleeding	2.9% 1/35

Additional Information

VP of Clinical Affairs

Torax Medical, Inc.

Phone: 651-361-8900

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60