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NCT03479489 · ClinicalTrials.gov registry record · NA

Use of Human Dehydrated Amnion Chorion Allograft in Closed Hemorroidectomy

A NA study of External Hemorrhoid and External Hemorrhoid Thrombosed, sponsored by MiMedx Group.

Completed
Registry status
NA
Development phase
11
Enrollment target
1
Study location

NCT03479489: Completed NA study of External Hemorrhoid and External Hemorrhoid Thrombosed, sponsored by MiMedx Group.

NCT03479489 is a NA study of External Hemorrhoid and External Hemorrhoid Thrombosed that has completed, run by MiMedx Group. The registered enrollment target is 11 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03479489, a NA study of External Hemorrhoid and External Hemorrhoid Thrombosed, has completed, sponsored by MiMedx Group.

COMPLETED
Registry status
NA
Development phase
11 participants
Enrollment target
1
Study location

Study Summary

The purpose of this study is to determine the safety and effectiveness of human dehydrated amnion chorion allograft in closed hemorrhoidectomy as assessed by patient and wound assessments.

Primary Outcome

The primary endpoint of the study is the change in patient reported pain across four categories from baseline within the 60 day follow-up period. In every patient diary, subjects will be asked to assess their pain on a 10 point Likert scale under the following conditions * Do you experience pain continuously? * Do you experience pain with activity? * Do you experience pain while sitting? * Do you experience pain with bowel movements?

Interventions

  • OTHER Human dehydrated amnion chorion allograft

Study Locations (1)

Colorado

  • Boulder Valley Surgical Associates - Boulder

Trial Details

FieldValue
Enrollment Target 11 participants
Start Date 2018-02-05
Est. Completion 2018-12-30
Phase NA
MiMedx Group

32 total trials

What the finished NCT03479489 record still lists

NCT03479489 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 11 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).

The record links to 2 conditions, with External Hemorrhoid appearing as the primary indexed condition, and to 1 intervention - of which Human dehydrated amnion chorion allograft is the first listed.

NCT03479489 reports a single indexed study location in Colorado.

Frequently Asked Questions

What is clinical trial NCT03479489 about?

NCT03479489 is a clinical study titled "Use of Human Dehydrated Amnion Chorion Allograft in Closed Hemorroidectomy". The purpose of this study is to determine the safety and effectiveness of human dehydrated amnion chorion allograft in closed hemorrhoidectomy as assessed by patient and wound assessments.

What is the current status of trial NCT03479489?

This trial is currently completed. It is a NA study. The enrollment target is 11 participants. The study started on 2018-02-05. Estimated completion is 2018-12-30.

What conditions does trial NCT03479489 study?

This clinical trial studies the following conditions: External Hemorrhoid, External Hemorrhoid Thrombosed.

What interventions are being tested in trial NCT03479489?

The interventions under investigation include: Human dehydrated amnion chorion allograft (OTHER).

Who is sponsoring clinical trial NCT03479489?

This trial is sponsored by MiMedx Group, which has 32 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03479489 being conducted?

This trial has 1 study location across Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

How this trial's enrollment target compares

Where NCT03479489's enrollment target sits among peer trials

11 1927th of 2000 higher than 74 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03479489, the US trial registry maintained by the National Library of Medicine. NCT03479489 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.