Trial of Latex Vs Non-latex Hemorrhoid Banding | NCT06625138

Studies
Trial of Latex Vs Non-latex Hemorrhoid Banding

NCT06625138

Sponsor

Huntington Memorial Hospital

Status

Recruiting

Last Update Posted

Oct 28, 2024Actual

Enrollment

164Estimated

Phase

Not Applicable

Conditions

Hemorrhoid
Hemorrhoid Bleeding

Interventions

Latex Band
Non-Latex Band

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2024

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 30, 2024Actual

Primary Completion Date

Oct 1, 2025Estimated

Completion Date

Oct 1, 2026Estimated

First Submitted Date

Sep 11, 2024

First Submission Date that Met QC Criteria

Oct 1, 2024

First Posted Date

Oct 3, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 24, 2024

Last Update Posted Date

Oct 28, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

This study will involve the recruitment of adult patients with symptomatic grade 2-3 internal 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 hypothesis is that non-latex hemorrhoidal bands are non-inferior to latex bands for the treatment of grade 2-3 internal hemorrhoids.

The secondary objective of the study is to compare banding-related adverse effects including pain, bleeding, and complications assessed both immediately and within 3 weeks following each hemorrhoidal banding.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

164Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Non-latex band	Experimental	Non-latex bands will be placed on hemorrhoids during banding	Device: Non-Latex Band
Latex band	Active Comparator	latex bands will be placed on hemorrhoids during banding	Device: Latex Band

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Latex Band	Device	Hemorrhoid banding with latex band	Latex band
Non-Latex Band

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Hemorrhoid Band Efficacy	hemorrhoidal bleeding and prolapse symptoms following ligation.	2-4 months

Secondary Outcomes

Measure	Description	Time Frame
Banding-related Adverse events	banding-related adverse events including pain, bleeding, and complications following hemorrhoidal banding	2-4 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Symptomatic grade 2-3 internal hemorrhoids undergoing rubber band ligation

Exclusion Criteria:

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".

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Adam Truong, MD	Contact	(626) 397-5896		adam.truong@huntingtonhealth.org

Overall Officials

Name	Affiliation	Role
Adam Truong, MD	Huntington Health	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Huntington Memorial Hospital	Recruiting	Pasadena	California	91105	United States

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Data will be available upon reasonable request

Types

Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code

Time Frame

from start of study for 2 years

Access Criteria

Data will be available upon reasonable request

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D006484	Hemorrhoids

Ancestor Terms

ID	Term
D012002	Rectal Diseases
D007410	Intestinal Diseases
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases

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Browse Branches

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