NCT02773420

Brief Summary

Purpose: The current study aims to evaluate the safety and effectiveness of the HET™ Bipolar System (Medtronic, Boulder, CO) for the treatment of grade I-II hemorrhoids in a prospective pilot study. This device was evaluated retrospectively in a limited cohort of 23 patients previously. Methods: Patients seen at a colorectal clinic in a single institution with grade I-II hemorrhoids are offered to participate in a prospective pilot trial. The HET device is a modified anoscope equipped with LED lighting, a tissue clamping mechanism and a bipolar energy source used to treat multiple hemorrhoidal columns in one sitting. Three columns of hemorrhoids are treated with 2 heat energy applications per column. The primary outcome is the treatment effect on hemorrhoid symptoms of bleeding, pain, prolapse, itching, and soiling. This is measured with a patient completed questionnaire documenting each symptom's frequency from 0 to 3 (i.e. 0 is \< 1x/month; 3 is daily) before therapy and at 3 weeks and 6 month follow-up. Post-treatment pain scores were recorded using the visual analog scale (VAS).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2015

Longer than P75 for not_applicable

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

August 1, 2015

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

May 12, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 16, 2016

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2019

Completed
Last Updated

June 3, 2021

Status Verified

May 1, 2021

Enrollment Period

3.4 years

First QC Date

May 12, 2016

Last Update Submit

May 28, 2021

Conditions

Hemorrhoids

Outcome Measures

Primary Outcomes (1)

  • HET Treatment effect on hemorrhoid symptoms

    The effect of HET on symptoms of bleeding, pain, prolapse, itching, and soiling.

    3 weeks to 6 months to 1 year

Secondary Outcomes (1)

  • Pain associated with HET

    Immediately to 3 weeks to 2 months

Study Arms (1)

HET application arm

EXPERIMENTAL

Patients with grade I-II internal hemorrhoids will undergo HET application

Procedure: HET Application

Interventions

HET ApplicationPROCEDURE

The HET device is a modified anoscope equipped with LED lighting, a tissue clamping mechanism and a bipolar energy source used to treat multiple hemorrhoidal columns in one sitting. Three columns of hemorrhoids were treated with 2 heat energy applications per column

HET application arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years of age and older.
  • Patients undergoing treatment for symptomatic hemorrhoids using the HET device

You may not qualify if:

  • Patients with inflammatory bowel disease, malignancy, anal fissures and those who are subject to anti-coagulation therapy with any drug other than aspirin.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Illinois at Chicago

Chicago, Illinois, 60612, United States

Location

Related Publications (3)

  • Kantsevoy SV, Bitner M. Nonsurgical treatment of actively bleeding internal hemorrhoids with a novel endoscopic device (with video). Gastrointest Endosc. 2013 Oct;78(4):649-53. doi: 10.1016/j.gie.2013.05.014. Epub 2013 Jul 25.

    PMID: 23891414RESULT

  • Pucher PH, Qurashi M, Howell AM, Faiz O, Ziprin P, Darzi A, Sodergren MH. Development and validation of a symptom-based severity score for haemorrhoidal disease: the Sodergren score. Colorectal Dis. 2015 Jul;17(7):612-8. doi: 10.1111/codi.12903.

    PMID: 25603811RESULT

  • Gerjy R, Lindhoff-Larson A, Sjodahl R, Nystrom PO. Randomized clinical trial of stapled haemorrhoidopexy performed under local perianal block versus general anaesthesia. Br J Surg. 2008 Nov;95(11):1344-51. doi: 10.1002/bjs.6379.

    PMID: 18844245RESULT

MeSH Terms

Conditions

Hemorrhoids

Condition Hierarchy (Ancestors)

Rectal DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Johan Nordenstam, MD

    University of Illinois at Chicago

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Surgery

Study Record Dates

First Submitted

May 12, 2016

First Posted

May 16, 2016

Study Start

August 1, 2015

Primary Completion

January 1, 2019

Study Completion

January 1, 2019

Last Updated

June 3, 2021

Record last verified: 2021-05

Locations

US(1)