Trial of Latex Vs Non-latex Hemorrhoid Banding
NO-Tex
Single-blinded Randomized Trial of Latex Vs Non-latex Hemorrhoid Banding
1 other identifier
interventional
164
1 country
1
Brief Summary
This study will involve the recruitment of adult patients with hemorrhoids for whom rubber band ligation is the recommended treatment. Patients will be randomized to receive banding with a latex band or non-latex band. Our goal will be to measure the performance of latex bands vs non-latex bands.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2024
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 30, 2024
CompletedFirst Submitted
Initial submission to the registry
September 11, 2024
CompletedFirst Posted
Study publicly available on registry
October 3, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2026
ExpectedOctober 28, 2024
October 1, 2024
1.1 years
September 11, 2024
October 24, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Hemorrhoid Band Efficacy
hemorrhoidal bleeding and prolapse symptoms following ligation.
2-4 months
Secondary Outcomes (1)
Banding-related Adverse events
2-4 months
Study Arms (2)
Non-latex band
EXPERIMENTALNon-latex bands will be placed on hemorrhoids during banding
Latex band
ACTIVE COMPARATORlatex bands will be placed on hemorrhoids during banding
Interventions
Eligibility Criteria
You may qualify if:
- Symptomatic grade 2-3 internal hemorrhoids undergoing rubber band ligation
You may not qualify if:
- Previous hemorrhoidal banding within the past year
- Known latex allergy
- Pregnancy
- Anticoagulation use
- Bleeding disorder
- Portal hypertension
- Inflammatory bowel disease
- Immunosuppression
- Functional neurologic disorder
- Pelvic floor dysfunction
- Any records flagged "break the glass" or "research opt out".
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Huntington Memorial Hospital
Pasadena, California, 91105, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Adam Truong, MD
Huntington Health
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Investigator
Study Record Dates
First Submitted
September 11, 2024
First Posted
October 3, 2024
Study Start
August 30, 2024
Primary Completion
October 1, 2025
Study Completion (Estimated)
October 1, 2026
Last Updated
October 28, 2024
Record last verified: 2024-10
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
- Time Frame
- from start of study for 2 years
- Access Criteria
- Data will be available upon reasonable request
Data will be available upon reasonable request