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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HET Arm | Other | Active arm. A single procedure with HET was used to treat Grade I and Grade II hemorrhoids |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HET Bipolar System | Device | The HET Bipolar System is used to treat hemorrhoids by bipolar ligation of the superior hemorrhoidal blood supply. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Post treatment at Month1, Month 3, Month 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Recurrence of Pre-procedure Symptoms | Recurrence of pre-procedure symptoms after initial improvement | Post treatment at Month 1, Month 3, and Month 6 |
| Recurrence of Symptoms That Had Resolved With Treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospitals Case Medical Center | Cleveland | Ohio | 44106 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | HET Arm | All subjects enrolled into the study were treated with the HET Bipolar System |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | HET Arm | Active arm. A single procedure with HET was used to treat Grade I and Grade II hemorrhoids HET Bipolar System: The HET Bipolar System is used to treat hemorrhoids by bipolar ligation of the superior hemorrhoidal blood supply. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | 18 participants included. 2 participants were lost to follow up. | Posted | Number | participants | Post treatment at Month1, Month 3, Month 6 |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | HET Arm |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| internal engorged hemorrhoids | Gastrointestinal disorders | The event was assessed as not related to the device, and was considered to be a recurrence of the study disease. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bleeding/Refractory Bleeding | Gastrointestinal disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director, Clinical Research | Medtronic Surgical Innovations | 508-452-4028 |
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| ID | Term |
|---|---|
| D006484 | Hemorrhoids |
| ID | Term |
|---|---|
| D012002 | Rectal Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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Number of patients with recurrence of symptoms defined as external thrombosed hemorrhoids, infection, mucous discharge, new fissure, stenosis and delayed healing.
| 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. | 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. | Post treatment at Month 1, Month 3, Month 6 |
| years |
|
| Gender | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Hemorrhoid grade | Hemorrhoids as graded on a scale of I-IV, with I being least symptomatic. Grade I: Bleeding hemorrhoids which do not prolapse outside the anal canal • Grade II: Hemorrhoids which prolapse, usually with defecation, but retract spontaneously | Number | participants |
|
| Pain (Y/N) | Number | participants |
|
| Bleeding (Y/N) | Number | participants |
|
| Previous Treatment Received (Y/N) | Number | participants |
|
|
| Secondary | Incidence of Recurrence of Pre-procedure Symptoms | Recurrence of pre-procedure symptoms after initial improvement | Posted | Number | participants | Post treatment at Month 1, Month 3, and Month 6 |
|
|
|
| Secondary | 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. | At Month 1, 3 and 6 the number of participants include patients followed through that time period. The remaining patients were lost to follow up. | Posted | Count of Participants | Participants | Post treatment at Month 1, Month 3, Month 6 |
|
|
|
| Secondary | 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. | At Month 1, 3 and 6 the number of participants include patients followed through that time period. The remaining patients were lost to follow up. | Posted | Number | participants | Post treatment at Month 1, Month 3, Month 6 |
|
|
|
| Secondary | 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. | At Month 1, 3 and 6 the number of participants include patients followed through that time period. The remaining patients were lost to follow up. | Posted | Mean | Standard Deviation | units on a scale | Post treatment at Month 1, Month 3, Month 6 |
|
|
|
| 2 |
| 20 |
| 5 |
| 20 |
|
| Bleeding | Gastrointestinal disorders |
|
| pain | Gastrointestinal disorders |
|
| urgency | Gastrointestinal disorders |
|
| skin tags | Gastrointestinal disorders |
|
| Gas/Gas Pain | Gastrointestinal disorders |
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| Intermittent Burning | Gastrointestinal disorders |
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| Internal Engorged Hemorrhoids | Gastrointestinal disorders |
|
| New Fissure | Gastrointestinal disorders |
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| Pain | Gastrointestinal disorders |
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| Pruritis | Gastrointestinal disorders |
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| Recurrence | Gastrointestinal disorders |
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| Skin Tags | Gastrointestinal disorders |
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| Thrombosed Hemorrhoids | Gastrointestinal disorders |
|
| Urgency | Gastrointestinal disorders |
|
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| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| Title | Measurements |
|---|---|
|
|
| Signs of Infection YES |
|
| Signs of Infection NO |
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| Mucous Discharge YES |
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| Mucous Discharge NO |
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| New Fissure YES |
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| New Fissure NO |
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| Delayed Healing YES |
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| Delayed Healing NO |
|
| Stenosis YES |
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| Stenosis NO |
|
| Other Conditions YES |
|
| Other Conditions No |
|
| Title | Measurements |
|---|---|
|