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
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
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
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: DeviceStandard of Care
Procedure
ActiveComparator Group · 1 Intervention: Nerve block · Intervention Types: ProcedureTreatment
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?
| Texas | 100.0% |
How old are they?
| 18 - 65 | 100.0% |
What site did they apply to?
| Oregon Health Sciences University | 100.0% |
What portion of applicants met pre-screening criteria?
| Met criteria | 100.0% |
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