HemorrhoidNO-TexNCT06625138
Trial of Latex vs Non-latex Hemorrhoid Banding
A study testing Latex Band and Non-Latex Band in people with Hemorrhoid and Hemorrhoid Bleeding, run by Huntington Memorial Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemorrhoid, Hemorrhoid Bleeding
- What is being tested?
- Latex Band and Non-Latex Band
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 164 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Aug 2024to 1 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Symptomatic grade 2-3 internal hemorrhoids undergoing rubber band ligation
Who cannot join
- Previous hemorrhoidal banding within the past year
- Known latex allergy
- Pregnancy
- Anticoagulation use
- Bleeding disorder
- Portal hypertension
Show all 11Show fewer
- Inflammatory bowel disease
- Immunosuppression
- Functional neurologic disorder
- Pelvic floor dysfunction
- Any records flagged "break the glass" or "research opt out".
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Huntington Memorial Hospital
Pasadena, California, 91105
Maureen PRS Coordinator, (626) 397-3877, maureen.uhlir@huntingtonhealth.org
adam.truong22@gmail.com
About this study
Official title: Single-blinded Randomized Trial of Latex vs Non-latex Hemorrhoid Banding
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.
Read the 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
- Being tested
- Latex Band, Non-Latex Band
- Keywords
- hemorrhoid, banding
- Medical subject headings
- Hemorrhoids
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Latex BandDevice
Hemorrhoid banding with latex band
Non-Latex BandDevice
Hemorrhoid banding with non-latex bands
| Study group | Role | What they receive |
|---|---|---|
| Non-latex band | Experimental | Non-latex bands will be placed on hemorrhoids during banding Receives: Device: Non-Latex Band |
| Latex band | Active comparator | latex bands will be placed on hemorrhoids during banding Receives: Device: Latex Band |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemorrhoid Band Efficacy
hemorrhoidal bleeding and prolapse symptoms following ligation.
Measured: 2-4 months
Secondary outcomes (1)
Banding-related Adverse events
banding-related adverse events including pain, bleeding, and complications following hemorrhoidal banding
Measured: 2-4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2024
- Study start30 Aug 2024
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemorrhoidStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 164 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Huntington Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adam Truong, Huntington Memorial Hospital
- Investigators
- Adam Truong, MD, Principal investigator, Huntington Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06625138
- Sponsor's protocol ID
- STUDY0003511
- Acronym
- NO-Tex
- Status last verified
- Sep 2026
- First submitted
- 11 Sep 2024
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Data will be available upon reasonable request
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-blinded Randomized Trial of Latex vs Non-latex Hemorrhoid Banding
- ClinicalTrials.gov ID
- NCT06625138
- Acronym / sponsor ID
- NO-Tex / STUDY0003511
- Conditions
- Hemorrhoid, Hemorrhoid Bleeding
- Keywords
- hemorrhoid, banding
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 164 participants (estimated)
- Lead sponsor
- Huntington Memorial HospitalUniversity, hospital or other
- Study start
- 30 Aug 2024 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 3 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-latex band | Experimental | Device: Non-Latex BandNon-latex bands will be placed on hemorrhoids during banding |
| Latex band | Active comparator | Device: Latex Bandlatex bands will be placed on hemorrhoids during banding |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Symptomatic grade 2-3 internal hemorrhoids undergoing rubber band ligation
Key exclusion criteria (11 listed)
- Previous hemorrhoidal banding within the past year
- Known latex allergy
- Pregnancy
- Anticoagulation use
- Bleeding disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Latex BandHemorrhoid banding with latex band | Device | Latex band |
| Non-Latex BandHemorrhoid banding with non-latex bands | Device | Non-latex band |
Primary outcome
Hemorrhoid Band Efficacy
Time frame: 2-4 months
hemorrhoidal bleeding and prolapse symptoms following ligation.
1 secondary outcome
Banding-related Adverse events
Time frame: 2-4 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
- Individual participant dataSharing planned: Yes. Data will be available upon reasonable request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Adam Truong, MD principal investigator
Huntington Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Latex Band and Non-Latex Band in people with Hemorrhoid and Hemorrhoid Bleeding, run by Huntington Memorial Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Adam Truong, MD ((626) 397-5896, adam.truong@huntingtonhealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hemorrhoid Band Efficacy (time frame: 2-4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2026.