NCT06625138

Trial of Latex Vs Non-latex Hemorrhoid Banding

Single-blinded Randomized Trial of Latex Vs Non-latex Hemorrhoid Banding

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 164 (estimated)
• Sponsor: Huntington Memorial Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hemorrhoid
• Hemorrhoid Bleeding

Interventions

Type	Name	Description
DEVICE	Latex Band	Hemorrhoid banding with latex band
DEVICE	Non-Latex Band	Hemorrhoid banding with non-latex bands

Timeline

• Start date: 2024-08-30
• Primary completion: 2025-10-01
• Completion: 2026-10-01
• First posted: 2024-10-03
• Last updated: 2024-10-28

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study