NCT01841970

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2013

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

April 22, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 29, 2013

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
2 years until next milestone

Results Posted

Study results publicly available

January 16, 2017

Completed
Last Updated

January 16, 2017

Status Verified

November 1, 2016

Enrollment Period

1.6 years

First QC Date

April 22, 2013

Results QC Date

May 6, 2016

Last Update Submit

November 17, 2016

Conditions

Hemorrhoids, Internal

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (4)

  • Incidence of Recurrence of Pre-procedure Symptoms

    Post treatment at Month 1, Month 3, and Month 6

  • Recurrence of Symptoms That Had Resolved With Treatment

    Post treatment at Month 1, Month 3, Month 6

  • Pain Recorded Yes or No on Visual Analog Scale (VAS)

    Post treatment at Month 1, Month 3, Month 6

  • Mean Pain Score Based on the Visual Analog Pain Scale

    Post treatment at Month 1, Month 3, Month 6

Study Arms (1)

HET Arm

OTHER

Active arm. A single procedure with HET was used to treat Grade I and Grade II hemorrhoids

Device: HET Bipolar System

Interventions

HET Bipolar SystemDEVICE

The HET Bipolar System is used to treat hemorrhoids by bipolar ligation of the superior hemorrhoidal blood supply.

HET Arm

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospitals Case Medical Center

Cleveland, Ohio, 44106, United States

Location

MeSH Terms

Conditions

Hemorrhoids

Condition Hierarchy (Ancestors)

Rectal DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesVascular DiseasesCardiovascular Diseases

Results Point of Contact

Title
Study Director, Clinical Research
Organization
Medtronic Surgical Innovations
508-452-4028

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 22, 2013

First Posted

April 29, 2013

Study Start

April 1, 2013

Primary Completion

November 1, 2014

Study Completion

January 1, 2015

Last Updated

January 16, 2017

Results First Posted

January 16, 2017

Record last verified: 2016-11

Locations

US(1)