Hemorrhoids, Internal
Conditions
Brief 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. 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.
Interventions
DEVICEHET Bipolar System
The HET Bipolar System is used to treat hemorrhoids by bipolar ligation of the superior hemorrhoidal blood supply.
Sponsors
Medtronic - MITG
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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 * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Resolution of Symptoms | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain Recorded Yes or No on Visual Analog Scale (VAS) | Post treatment at Month 1, Month 3, Month 6 | Patient reported pain on 10 point scale where 0 =No Pain and \> 0 = Pain with 10 being the worst. |
| Mean Pain Score Based on the Visual Analog Pain Scale | Post treatment at Month 1, Month 3, Month 6 | 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. |
| Incidence of Recurrence of Pre-procedure Symptoms | Post treatment at Month 1, Month 3, and Month 6 | Recurrence of pre-procedure symptoms after initial improvement |
| Recurrence of Symptoms That Had Resolved With Treatment | Post treatment at Month 1, Month 3, Month 6 | Number of patients with recurrence of symptoms defined as external thrombosed hemorrhoids, infection, mucous discharge, new fissure, stenosis and delayed healing. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 20 |
| Total | 20 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 8 |
| Overall Study | Physician Decision | 2 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | HET Arm |
|---|---|
| Age, Continuous | 56.6 years STANDARD_DEVIATION 18.1 |
| Bleeding (Y/N) Bleeding No | 0 participants |
| Bleeding (Y/N) Bleeding Yes | 20 participants |
| Gender Female | 11 Participants |
| Gender Male | 9 Participants |
| Hemorrhoid grade Grade I | 7 participants |
| Hemorrhoid grade Grade II | 13 participants |
| Pain (Y/N) Pain No | 7 participants |
| Pain (Y/N) Pain Yes | 13 participants |
| Previous Treatment Received (Y/N) Previous Treatment No | 0 participants |
| Previous Treatment Received (Y/N) Previous Treatment Yes | 20 participants |
| Region of Enrollment United States | 20 participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 5 / 20 |
| serious Total, serious adverse events | 2 / 20 |
Outcome results
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
Time frame: Post treatment at Month1, Month 3, Month 6
Population: 18 participants included. 2 participants were lost to follow up.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| HET Arm | Number of Participants With Resolution of Symptoms | 18 participants |
Secondary
Incidence of Recurrence of Pre-procedure Symptoms
Recurrence of pre-procedure symptoms after initial improvement
Time frame: Post treatment at Month 1, Month 3, and Month 6
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| HET Arm | Incidence of Recurrence of Pre-procedure Symptoms | Recurrence Yes | 0 participants |
| HET Arm | Incidence of Recurrence of Pre-procedure Symptoms | Recurrence No | 18 participants |
| Month 3 | Incidence of Recurrence of Pre-procedure Symptoms | Recurrence Yes | 3 participants |
| Month 3 | Incidence of Recurrence of Pre-procedure Symptoms | Recurrence No | 8 participants |
| Month 6 | Incidence of Recurrence of Pre-procedure Symptoms | Recurrence Yes | 4 participants |
| Month 6 | Incidence of Recurrence of Pre-procedure Symptoms | Recurrence No | 5 participants |
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.
Time frame: Post treatment at Month 1, Month 3, Month 6
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| HET Arm | Mean Pain Score Based on the Visual Analog Pain Scale | 0.7 units on a scale | Standard Deviation 1.57 |
| Month 3 | Mean Pain Score Based on the Visual Analog Pain Scale | 0.4 units on a scale | Standard Deviation 1.21 |
| Month 6 | Mean Pain Score Based on the Visual Analog Pain Scale | 0.1 units on a scale | Standard Deviation 0.33 |
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.
Time frame: Post treatment at Month 1, Month 3, Month 6
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| HET Arm | Pain Recorded Yes or No on Visual Analog Scale (VAS) | Pain YES | 4 participants |
| HET Arm | Pain Recorded Yes or No on Visual Analog Scale (VAS) | Pain NO | 14 participants |
| Month 3 | Pain Recorded Yes or No on Visual Analog Scale (VAS) | Pain YES | 1 participants |
| Month 3 | Pain Recorded Yes or No on Visual Analog Scale (VAS) | Pain NO | 10 participants |
| Month 6 | Pain Recorded Yes or No on Visual Analog Scale (VAS) | Pain YES | 1 participants |
| Month 6 | Pain Recorded Yes or No on Visual Analog Scale (VAS) | Pain NO | 8 participants |
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.
Time frame: Post treatment at Month 1, Month 3, Month 6
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| HET Arm | Recurrence of Symptoms That Had Resolved With Treatment | Stenosis YES | 0 Participants |
| HET Arm | Recurrence of Symptoms That Had Resolved With Treatment | Mucous Discharge NO | 18 Participants |
| HET Arm | Recurrence of Symptoms That Had Resolved With Treatment | Signs of Infection YES | 0 Participants |
| HET Arm | Recurrence of Symptoms That Had Resolved With Treatment | Delayed Healing NO | 18 Participants |
| HET Arm | Recurrence of Symptoms That Had Resolved With Treatment | New Fissure YES | 2 Participants |
| HET Arm | Recurrence of Symptoms That Had Resolved With Treatment | External Thrombosed Hemorrhoids - YES | 0 Participants |
| HET Arm | Recurrence of Symptoms That Had Resolved With Treatment | Delayed Healing YES | 0 Participants |
| HET Arm | Recurrence of Symptoms That Had Resolved With Treatment | New Fissure NO | 16 Participants |
| HET Arm | Recurrence of Symptoms That Had Resolved With Treatment | Stenosis NO | 18 Participants |
| HET Arm | Recurrence of Symptoms That Had Resolved With Treatment | Signs of Infection NO | 18 Participants |
| HET Arm | Recurrence of Symptoms That Had Resolved With Treatment | Other Conditions No | 15 Participants |
| HET Arm | Recurrence of Symptoms That Had Resolved With Treatment | External Thrombosed Hemorrhoids - NO | 18 Participants |
| HET Arm | Recurrence of Symptoms That Had Resolved With Treatment | Mucous Discharge YES | 0 Participants |
| HET Arm | Recurrence of Symptoms That Had Resolved With Treatment | Other Conditions YES | 2 Participants |
| Month 3 | Recurrence of Symptoms That Had Resolved With Treatment | Stenosis YES | 0 Participants |
| Month 3 | Recurrence of Symptoms That Had Resolved With Treatment | External Thrombosed Hemorrhoids - NO | 11 Participants |
| Month 3 | Recurrence of Symptoms That Had Resolved With Treatment | External Thrombosed Hemorrhoids - YES | 0 Participants |
| Month 3 | Recurrence of Symptoms That Had Resolved With Treatment | Signs of Infection YES | 0 Participants |
| Month 3 | Recurrence of Symptoms That Had Resolved With Treatment | Signs of Infection NO | 11 Participants |
| Month 3 | Recurrence of Symptoms That Had Resolved With Treatment | Mucous Discharge YES | 0 Participants |
| Month 3 | Recurrence of Symptoms That Had Resolved With Treatment | Mucous Discharge NO | 11 Participants |
| Month 3 | Recurrence of Symptoms That Had Resolved With Treatment | New Fissure YES | 0 Participants |
| Month 3 | Recurrence of Symptoms That Had Resolved With Treatment | New Fissure NO | 11 Participants |
| Month 3 | Recurrence of Symptoms That Had Resolved With Treatment | Delayed Healing YES | 0 Participants |
| Month 3 | Recurrence of Symptoms That Had Resolved With Treatment | Delayed Healing NO | 11 Participants |
| Month 3 | Recurrence of Symptoms That Had Resolved With Treatment | Stenosis NO | 11 Participants |
| Month 3 | Recurrence of Symptoms That Had Resolved With Treatment | Other Conditions YES | 2 Participants |
| Month 3 | Recurrence of Symptoms That Had Resolved With Treatment | Other Conditions No | 9 Participants |
| Month 6 | Recurrence of Symptoms That Had Resolved With Treatment | Other Conditions YES | 1 Participants |
| Month 6 | Recurrence of Symptoms That Had Resolved With Treatment | Delayed Healing NO | 9 Participants |
| Month 6 | Recurrence of Symptoms That Had Resolved With Treatment | Mucous Discharge YES | 0 Participants |
| Month 6 | Recurrence of Symptoms That Had Resolved With Treatment | Signs of Infection NO | 9 Participants |
| Month 6 | Recurrence of Symptoms That Had Resolved With Treatment | Stenosis YES | 0 Participants |
| Month 6 | Recurrence of Symptoms That Had Resolved With Treatment | Signs of Infection YES | 0 Participants |
| Month 6 | Recurrence of Symptoms That Had Resolved With Treatment | External Thrombosed Hemorrhoids - NO | 9 Participants |
| Month 6 | Recurrence of Symptoms That Had Resolved With Treatment | Stenosis NO | 9 Participants |
| Month 6 | Recurrence of Symptoms That Had Resolved With Treatment | External Thrombosed Hemorrhoids - YES | 0 Participants |
| Month 6 | Recurrence of Symptoms That Had Resolved With Treatment | New Fissure NO | 9 Participants |
| Month 6 | Recurrence of Symptoms That Had Resolved With Treatment | New Fissure YES | 0 Participants |
| Month 6 | Recurrence of Symptoms That Had Resolved With Treatment | Other Conditions No | 8 Participants |
| Month 6 | Recurrence of Symptoms That Had Resolved With Treatment | Delayed Healing YES | 0 Participants |
| Month 6 | Recurrence of Symptoms That Had Resolved With Treatment | Mucous Discharge NO | 9 Participants |