Trial Outcomes & Findings for Safety and Efficacy Study of HET Bipolar System for Treatment of Stage I and Stage II Hemorrhoids (NCT NCT01841970)

NCT ID: NCT01841970

Last Updated: 2017-01-16

Results Overview

The primary endpoint analysis was the resolution of symptoms, including resolution of bleeding and prolapse, if present prior to treatment

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 20 participants
• Primary outcome timeframe: Post treatment at Month1, Month 3, Month 6
• Results posted on: 2017-01-16

Participant Flow

Participant milestones

Measure	HET Arm All subjects enrolled into the study were treated with the HET Bipolar System
Overall Study STARTED	20
Overall Study COMPLETED	9
Overall Study NOT COMPLETED	11

Reasons for withdrawal

Measure	HET Arm All subjects enrolled into the study were treated with the HET Bipolar System
Overall Study Withdrawal by Subject	1
Overall Study Physician Decision	2
Overall Study Lost to Follow-up	8

Baseline Characteristics

Safety and Efficacy Study of HET Bipolar System for Treatment of Stage I and Stage II Hemorrhoids

Baseline characteristics by cohort

Measure	HET Arm n=20 Participants 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.
Age, Continuous	56.6 years STANDARD_DEVIATION 18.1 • n=5 Participants
Gender Female	11 Participants n=5 Participants
Gender Male	9 Participants n=5 Participants
Region of Enrollment United States	20 participants n=5 Participants
Hemorrhoid grade Grade I	7 participants n=5 Participants
Hemorrhoid grade Grade II	13 participants n=5 Participants
Pain (Y/N) Pain Yes	13 participants n=5 Participants
Pain (Y/N) Pain No	7 participants n=5 Participants
Bleeding (Y/N) Bleeding Yes	20 participants n=5 Participants
Bleeding (Y/N) Bleeding No	0 participants n=5 Participants
Previous Treatment Received (Y/N) Previous Treatment Yes	20 participants n=5 Participants
Previous Treatment Received (Y/N) Previous Treatment No	0 participants n=5 Participants

PRIMARY outcome

Timeframe: Post treatment at Month1, Month 3, Month 6

Population: 18 participants included. 2 participants were lost to follow up.

The primary endpoint analysis was the resolution of symptoms, including resolution of bleeding and prolapse, if present prior to treatment

Outcome measures

Measure	HET Arm n=18 Participants	Month 3	Month 6
Number of Participants With Resolution of Symptoms	18 participants	—	—

SECONDARY outcome

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

Recurrence of pre-procedure symptoms after initial improvement

Outcome measures

Measure	HET Arm n=18 Participants	Month 3 n=11 Participants	Month 6 n=9 Participants
Incidence of Recurrence of Pre-procedure Symptoms Recurrence Yes	0 participants	3 participants	4 participants
Incidence of Recurrence of Pre-procedure Symptoms Recurrence No	18 participants	8 participants	5 participants

SECONDARY outcome

Timeframe: 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.

Number of patients with recurrence of symptoms defined as external thrombosed hemorrhoids, infection, mucous discharge, new fissure, stenosis and delayed healing.

Outcome measures

Measure	HET Arm n=18 Participants	Month 3 n=11 Participants	Month 6 n=9 Participants
Recurrence of Symptoms That Had Resolved With Treatment External Thrombosed Hemorrhoids - NO	18 Participants	11 Participants	9 Participants
Recurrence of Symptoms That Had Resolved With Treatment External Thrombosed Hemorrhoids - YES	0 Participants	0 Participants	0 Participants
Recurrence of Symptoms That Had Resolved With Treatment Signs of Infection YES	0 Participants	0 Participants	0 Participants
Recurrence of Symptoms That Had Resolved With Treatment Signs of Infection NO	18 Participants	11 Participants	9 Participants
Recurrence of Symptoms That Had Resolved With Treatment Mucous Discharge YES	0 Participants	0 Participants	0 Participants
Recurrence of Symptoms That Had Resolved With Treatment Mucous Discharge NO	18 Participants	11 Participants	9 Participants
Recurrence of Symptoms That Had Resolved With Treatment New Fissure YES	2 Participants	0 Participants	0 Participants
Recurrence of Symptoms That Had Resolved With Treatment New Fissure NO	16 Participants	11 Participants	9 Participants
Recurrence of Symptoms That Had Resolved With Treatment Delayed Healing YES	0 Participants	0 Participants	0 Participants
Recurrence of Symptoms That Had Resolved With Treatment Delayed Healing NO	18 Participants	11 Participants	9 Participants
Recurrence of Symptoms That Had Resolved With Treatment Stenosis YES	0 Participants	0 Participants	0 Participants
Recurrence of Symptoms That Had Resolved With Treatment Stenosis NO	18 Participants	11 Participants	9 Participants
Recurrence of Symptoms That Had Resolved With Treatment Other Conditions YES	2 Participants	2 Participants	1 Participants
Recurrence of Symptoms That Had Resolved With Treatment Other Conditions No	15 Participants	9 Participants	8 Participants

SECONDARY outcome

Timeframe: 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.

Patient reported pain on 10 point scale where 0 =No Pain and > 0 = Pain with 10 being the worst.

Outcome measures

Measure	HET Arm n=18 Participants	Month 3 n=11 Participants	Month 6 n=9 Participants
Pain Recorded Yes or No on Visual Analog Scale (VAS) Pain YES	4 participants	1 participants	1 participants
Pain Recorded Yes or No on Visual Analog Scale (VAS) Pain NO	14 participants	10 participants	8 participants

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	HET Arm n=18 Participants	Month 3 n=11 Participants	Month 6 n=9 Participants
Mean Pain Score Based on the Visual Analog Pain Scale	0.7 units on a scale Standard Deviation 1.57	0.4 units on a scale Standard Deviation 1.21	0.1 units on a scale Standard Deviation 0.33

Adverse Events

HET Arm

Serious events: 2 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Measure	HET Arm n=20 participants at risk
Gastrointestinal disorders internal engorged hemorrhoids	5.0% 1/20 • Number of events 1
Gastrointestinal disorders Bleeding	5.0% 1/20 • Number of events 1
Gastrointestinal disorders pain	5.0% 1/20 • Number of events 1
Gastrointestinal disorders urgency	5.0% 1/20 • Number of events 1
Gastrointestinal disorders skin tags	5.0% 1/20 • Number of events 1

Other adverse events

Measure	HET Arm n=20 participants at risk
Gastrointestinal disorders Bleeding/Refractory Bleeding	25.0% 5/20
Gastrointestinal disorders Gas/Gas Pain	10.0% 2/20
Gastrointestinal disorders Intermittent Burning	5.0% 1/20
Gastrointestinal disorders Internal Engorged Hemorrhoids	5.0% 1/20
Gastrointestinal disorders New Fissure	10.0% 2/20
Gastrointestinal disorders Pain	15.0% 3/20
Gastrointestinal disorders Pruritis	5.0% 1/20
Gastrointestinal disorders Recurrence	20.0% 4/20
Gastrointestinal disorders Skin Tags	5.0% 1/20
Gastrointestinal disorders Thrombosed Hemorrhoids	5.0% 1/20
Gastrointestinal disorders Urgency	5.0% 1/20

Additional Information

Study Director, Clinical Research

Medtronic Surgical Innovations

Phone: 508-452-4028

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place