Hemorrhoids, InternalNCT01841970
Safety and Efficacy Study of HET Bipolar System for Treatment of Stage I and Stage II Hemorrhoids
A study testing HET Bipolar System in people with Hemorrhoids, Internal, run by Medtronic - MITG at 1 site in United States.
Trial summary
Hemorrhoids are vascular cushions in the anal canal. People are normally born with hemorrhoids, and the presence of hemorrhoids does not imply disease. However, hemorrhoids typically cause symptoms when they enlarge over time. There are two types of hemorrhoids- External Hemorrhoids and Internal Hemorrhoids. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Hemorrhoids, Internal
- What is being tested?
- HET Bipolar System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2013to Jan 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject over 21 years of age
- General good health
- Subject undergoing elective treatment for Stage I or Stage II internal hemorrhoids
- Chronic bleeding from Stage I or Stage II internal hemorrhoids (at least weekly occurrence
- Failure of prior medical management
Who cannot join
- Under 21 years of age.
- Gastrointestinal bleeding from source other than their internal hemorrhoids
- Active proctitis
- Inflammatory bowel disease
- HIV positive or immunocompromised
- Rectal wall prolapse
Show all 17Show fewer
- Stage III and Stage IV hemorrhoids
- Medical conditions requiring anticoagulants and/or subject to receive anticoagulants within 7 days of initial examination
- Pregnancy
- Rectal malignancy
- Hepatitis C
- Liver cirrhosis
- End stage renal disease
- Receiving chemotherapy
- Advanced malignancy
- Documented bleeding diathesis
- Treatment with an investigational drug or medical device in the past 30 days
Trial locations and contacts
1 site in 1 country.
United States1 site
University Hospitals Case Medical Center
Cleveland, Ohio, 44106
About this study
Official title: Multi-Center, Prospective Study of the Safety and Efficacy of the HET Bipolar System for Treatment of Stage I and Stage II Hemorrhoids
Hemorrhoids are vascular cushions in the anal canal. People are normally born with hemorrhoids, and the presence of hemorrhoids does not imply disease. However, hemorrhoids typically cause symptoms when they enlarge over time. There are two types of hemorrhoids- External Hemorrhoids and Internal Hemorrhoids.
Current minimally invasive technologies for the treatment of internal hemorrhoids are associated with several drawbacks that include high rate of recurrence and a need for repetitive procedures, frequent post-procedural pain or significant discomfort, intra-operative pain and technically demanding. The purpose of this study is to determine whether the HET Bipolar System is safe and effective in the treatment of Stage I and Stage II hemorrhoids (internal hemorrhoids). The HET Bipolar System is a new alternative device for the minimally invasive treatment of Stage I and Stage II hemorrhoids that incorporate design features with the intent of resolving each of the major limitations of currently available technology.
Read the detailed description
In this study, the investigators will use the HET Bipolar System for the treatment of Stage I and Stage II hemorrhoids, where significant tissue prolapse is not present. The hemorrhoids are treated by bipolar ligation of the superior hemorrhoidal blood supply.
Each prospective subject will be screened for inclusion and exclusion criteria at least one week prior to treatment. All patients undergoing treatment will review and sign the study Informed Consent prior to their procedure.
One to three internal hemorrhoids will be treated in one therapeutic session. The number will be based on the investigator's judgment of which quadrants are symptomatic. Evaluations will be recorded for all treated subjects immediately following treatment. Subjects will be followed at 1, 3, and 6 months post procedure unless complications are reported between scheduled follow-up dates. At each post treatment follow-up, a report will be made of pain/discomfort, bleeding, medication use, itching, presence of adverse events or complications and need for supplemental treatment. Face-to-face follow-up evaluations will include anoscopic evaluation and assessment of hemorrhoid and other relevant symptoms.
- Conditions
- Hemorrhoids, Internal
- Being tested
- HET Bipolar System
- Medical subject headings
- Hemorrhoids
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HET Bipolar SystemDevice
The HET Bipolar System is used to treat hemorrhoids by bipolar ligation of the superior hemorrhoidal blood supply.
| Study group | Role | What they receive |
|---|---|---|
| HET Arm | Other | Active arm. A single procedure with HET was used to treat Grade I and Grade II hemorrhoids Receives: Device: HET Bipolar System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Resolution of Symptoms
The primary endpoint analysis was the resolution of symptoms, including resolution of bleeding and prolapse, if present prior to treatment
Measured: Post treatment at Month1, Month 3, Month 6
Secondary outcomes (4)
Incidence of Recurrence of Pre-procedure Symptoms
Recurrence of pre-procedure symptoms after initial improvement
Measured: Post treatment at Month 1, Month 3, and Month 6
Recurrence of Symptoms That Had Resolved With Treatment
Number of patients with recurrence of symptoms defined as external thrombosed hemorrhoids, infection, mucous discharge, new fissure, stenosis and delayed healing.
Measured: Post treatment at Month 1, Month 3, Month 6
Pain Recorded Yes or No on Visual Analog Scale (VAS)
Patient reported pain on 10 point scale where 0 =No Pain and > 0 = Pain with 10 being the worst.
Measured: Post treatment at Month 1, Month 3, Month 6
Mean Pain Score Based on the Visual Analog Pain Scale
Mean pain score based on the Visual Analog pain scale. Patient reported pain on 10 point scale where 0 =No Pain and > 0 = Pain with 10 being the worst.
Measured: Post treatment at Month 1, Month 3, Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2013 (estimated)
- Study startApr 2013
- Primary completionNov 2014
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Hemorrhoids, InternalStudies of the same condition, open and under way.
- More trials run by Medtronic - MITGThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic - MITG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01841970
- Sponsor's protocol ID
- HET-12-001
- Status last verified
- Nov 2016
- First submitted
- 22 Apr 2013
- Last updated
- 16 Jan 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-Center, Prospective Study of the Safety and Efficacy of the HET Bipolar System for Treatment of Stage I and Stage II Hemorrhoids
- ClinicalTrials.gov ID
- NCT01841970
- Acronym / sponsor ID
- HET-12-001
- Conditions
- Hemorrhoids, Internal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Medtronic - MITGIndustry (pharma, biotech, devices)
- Study start
- Apr 2013
- Primary completion
- Nov 2014 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 29 Apr 2013 (estimated)
- Results
- Posted 16 Jan 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Hemorrhoids are vascular cushions in the anal canal. People are normally born with hemorrhoids, and the presence of hemorrhoids does not imply disease. However, hemorrhoids typically cause symptoms when they enlarge over time. There are two types of hemorrhoids- External Hemorrhoids and Internal Hemorrhoids.
Current minimally invasive technologies for the treatment of internal hemorrhoids are associated with several drawbacks that include high rate of recurrence and a need for repetitive procedures, frequent post-procedural pain or significant discomfort, intra-operative pain and technically demanding. The purpose of this study is to determine whether the HET Bipolar System is safe and effective in the treatment of Stage I and Stage II hemorrhoids (internal hemorrhoids). The HET Bipolar System is a new alternative device for the minimally invasive treatment of Stage I and Stage II hemorrhoids that incorporate design features with the intent of resolving each of the major limitations of currently available technology.
Detailed description
In this study, the investigators will use the HET Bipolar System for the treatment of Stage I and Stage II hemorrhoids, where significant tissue prolapse is not present. The hemorrhoids are treated by bipolar ligation of the superior hemorrhoidal blood supply.
Each prospective subject will be screened for inclusion and exclusion criteria at least one week prior to treatment. All patients undergoing treatment will review and sign the study Informed Consent prior to their procedure.
One to three internal hemorrhoids will be treated in one therapeutic session. The number will be based on the investigator's judgment of which quadrants are symptomatic. Evaluations will be recorded for all treated subjects immediately following treatment. Subjects will be followed at 1, 3, and 6 months post procedure unless complications are reported between scheduled follow-up dates. At each post treatment follow-up, a report will be made of pain/discomfort, bleeding, medication use, itching, presence of adverse events or complications and need for supplemental treatment. Face-to-face follow-up evaluations will include anoscopic evaluation and assessment of hemorrhoid and other relevant symptoms.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HET Arm | Other | Device: HET Bipolar SystemActive arm. A single procedure with HET was used to treat Grade I and Grade II hemorrhoids |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subject over 21 years of age
- General good health
- Subject undergoing elective treatment for Stage I or Stage II internal hemorrhoids
- Chronic bleeding from Stage I or Stage II internal hemorrhoids (at least weekly occurrence
- Failure of prior medical management
Key exclusion criteria (17 listed)
- Under 21 years of age.
- Gastrointestinal bleeding from source other than their internal hemorrhoids
- Active proctitis
- Inflammatory bowel disease
- HIV positive or immunocompromised
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 |
|---|---|---|
| HET Bipolar SystemThe HET Bipolar System is used to treat hemorrhoids by bipolar ligation of the superior hemorrhoidal blood supply. | Device | HET Arm |
Primary outcome
Number of Participants With Resolution of Symptoms
Time frame: Post treatment at Month1, Month 3, Month 6
The primary endpoint analysis was the resolution of symptoms, including resolution of bleeding and prolapse, if present prior to treatment
4 secondary outcomes
Incidence of Recurrence of Pre-procedure Symptoms
Time frame: Post treatment at Month 1, Month 3, and Month 6
Recurrence of Symptoms That Had Resolved With Treatment
Time frame: Post treatment at Month 1, Month 3, Month 6
Pain Recorded Yes or No on Visual Analog Scale (VAS)
Time frame: Post treatment at Month 1, Month 3, Month 6
Mean Pain Score Based on the Visual Analog Pain Scale
Time frame: Post treatment at Month 1, Month 3, Month 6
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HET Bipolar System in people with Hemorrhoids, Internal, run by Medtronic - MITG 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 5 inclusion and 17 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: finished, as of the sponsor's last update on 16 Jan 2017. 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?
Yes. Results are posted in the registry (first posted 16 Jan 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Resolution of Symptoms (time frame: Post treatment at Month1, Month 3, Month 6). 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 16 Jan 2017.