Study: NCT04146467

Adverse event: Lower GI Bleed
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Not related to device or procedure.
Frequency: 1 affected / 65 at risk

Adverse event: Appendicitis
Serious: yes
Organ System: General disorders
Notes: Not related to device or procedure.
Frequency: 1 affected / 65 at risk

Adverse event: Nephrolithiasis
Serious: yes
Organ System: Renal and urinary disorders
Notes: Not related to device or procedure.
Frequency: 1 affected / 65 at risk

Adverse event: Edema/Swelling
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Expected Treatment Effect
Frequency: 60 affected / 65 at risk

Adverse event: Temporary sensory nerve injury (loss of sensation)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Expected Treatment Effect
Frequency: 57 affected / 65 at risk

Adverse event: Ecchymosis/ bruising
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Expected Treatment Effect
Frequency: 36 affected / 65 at risk

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Expected Treatment Effect
Frequency: 32 affected / 65 at risk

Adverse event: Crepitus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Expected Treatment Effect
Frequency: 27 affected / 65 at risk

Adverse event: Pain/tenderness
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Expected Treatment Effect
Frequency: 16 affected / 65 at risk

Adverse event: Nodules/subcutaneous lumps (migratory firmness)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Expected Treatment Effect
Frequency: 8 affected / 65 at risk

Adverse event: Temporary motor nerve Injury (nerve weakness, muscle atrophy, twitching, and paralysis)
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 65 at risk

Adverse event: Pruritus/itching (not related to nerve injury)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 65 at risk

Adverse event: Edema/Swelling
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Expected Treatment Effect
Frequency: 14 affected / 17 at risk

Adverse event: Temporary sensory nerve injury (loss of sensation)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Expected Treatment Effect
Frequency: 5 affected / 17 at risk

Adverse event: Ecchymosis/ bruising
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Expected Treatment Effect
Frequency: 10 affected / 17 at risk

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Expected Treatment Effect
Frequency: 3 affected / 17 at risk

Adverse event: Crepitus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Expected Treatment Effect
Frequency: 3 affected / 17 at risk

Adverse event: Pain/tenderness
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Expected Treatment Effect
Frequency: 5 affected / 17 at risk

Adverse event: Nodules/subcutaneous lumps (migratory firmness)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Expected Treatment Effect
Frequency: 6 affected / 17 at risk

Adverse event: Temporary motor nerve Injury (nerve weakness, muscle atrophy, twitching, and paralysis)
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 17 at risk