Cryoablation for Morton's Neuroma

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Oregon Health Sciences University, Portland, ORMorton's Neuroma+2 MoreCryoablation - Device
Eligibility
18 - 105
All Sexes
What conditions do you have?
Select

Study Summary

This trial is studying whether cryoablation (freezing the nerve) is better than a corticosteroid injection for treating Morton's neuroma.

Eligible Conditions
  • Morton's Neuroma

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

5 Primary · 0 Secondary · Reporting Duration: 1 year post procedure

1 year post procedure
Changes in quality of life
Changes pain and function due to neuroma
Changes to function
Incidence of Treatment - Emergent Adverse Events
Réponse in pain

Trial Safety

Safety Progress

1 of 3

Side Effects for

3/Arm B - Tremelimumab + TACE
100%Hyponatremia
92%Hypoalbuminemia
92%Lymphocyte count decreased
92%Anemia
83%Alanine aminotransferase increased
83%Alkaline phosphatase increased
83%Aspartate aminotransferase increased
75%Hypophosphatemia
75%Activated partial thromboplastin time prolonged
67%Fatigue
67%Nausea
67%Constipation
67%Pain
67%Blood bilirubin increased
58%Fever
58%Insomnia
50%Serum amylase increased
50%Abdominal pain
50%Diarrhea
50%Creatinine increased
42%Hyperkalemia
42%Rash maculo-papular
42%Cough
42%Hypokalemia
42%Anorexia
42%Hypercalcemia
42%Platelet count decreased
25%Dehydration
25%Hypomagnesemia
25%Vomiting
25%Ascites
25%Hypocalcemia
25%Back pain
17%Gastrointestinal disorders - Other, gastrointestinal disorders - Other, cramping
17%Edema limbs
17%Hypermagnesemia
17%Bloating
17%Hypernatremia
17%Lipase increased
17%Colitis
17%Neutrophil count decreased
17%Weight loss
17%Blurred vision
17%Confusion
17%Hypotension
17%Headache
17%Dizziness
17%Dyspnea
17%Hyperhidrosis
8%Malaise
8%Dry skin
8%Alopecia
8%Hypoxia
8%Hypertension
8%Intra-abdominal hemorrhage
8%Bronchial infection
8%Anxiety
8%Ileus
8%Lung infection
8%Palmar-plantar erythrodysesthesia syndrome
8%Peripheral motor neuropathy
8%Skin and subcutaneous tissue disorders - Other, skin discoloration
8%Gastroesophageal reflux disease
8%Infections and infestations - Other, C. Diff infection
8%Skin hyperpigmentation
8%Edema trunk
8%Hiccups
8%Papulopustular rash
8%Pneumothorax
8%Skin infection
8%Myalgia
8%Urinary frequency
8%Flushing
8%Skin and subcutaneous tissue disorders - Other, skin peeling - bil. Hands
8%Palpitations
8%Atrial fibrillation
8%Gastrointestinal disorders - Other, Inguinal hernia
8%Muscle weakness left-sided
8%Abdominal distension
8%Adrenal insufficiency
8%Allergic rhinitis
8%Dysgeusia
8%Erectile dysfunction
8%Hypothyroidism
8%Flu like symptoms
8%Hoarseness: voice changes
8%Depression
8%Dry mouth
8%Gastric ulcer
8%Vertigo
8%Hyperthyroidism
8%Generalized muscle weakness
8%Seizure
8%CPK increased
8%Dry eye
8%Atrial flutter
8%Hypersomnia
8%Respiratory, thoracic and mediastinal disorders - Other, Pneumonia
8%Epistaxis
8%Sore throat
8%Rash acneiform
This histogram enumerates side effects from a completed 2017 Phase 1 & 2 trial (NCT01853618) in the 3/Arm B - Tremelimumab + TACE ARM group. Side effects include: Hyponatremia with 100%, Hypoalbuminemia with 92%, Lymphocyte count decreased with 92%, Anemia with 92%, Alanine aminotransferase increased with 83%.

Trial Design

2 Treatment Groups

Standard of Care
1 of 2
Study
1 of 2

Active Control

Experimental Treatment

32 Total Participants · 2 Treatment Groups

Primary Treatment: Cryoablation · No Placebo Group · N/A

Study
Device
Experimental Group · 1 Intervention: Cryoablation · Intervention Types: Device
Standard of Care
Procedure
ActiveComparator Group · 1 Intervention: Nerve block · Intervention Types: Procedure
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cryoablation
2016
Completed Phase 2
~980

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 1 year post procedure

Who is running the clinical trial?

Oregon Health and Science UniversityLead Sponsor
905 Previous Clinical Trials
6,830,411 Total Patients Enrolled
Claire KaufmanPrincipal InvestigatorOregon Health and Science University

Eligibility Criteria

Age 18 - 105 · All Participants · 4 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have tried using shoe inserts, special shoes or pads for your feet for four weeks but they have not improved your condition.

Who else is applying?

What state do they live in?
Texas100.0%
How old are they?
18 - 65100.0%
What site did they apply to?
Oregon Health Sciences University100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%

Frequently Asked Questions

What is the numerical extent of participants in this trial?

"Affirmative. Information found on clinicaltrials.gov indicates that this research is actively seeking participants, having been posted on July 25th 2022 and updated most recently in August 11th 2022. At present, 32 individuals are being recruited at a single location." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.