A Multicenter Prospective Clinical Study of Endoscopic Foam Sclerotherapy for Internal Hemorrhoids

May 18, 2020 updated by: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
"Internal hemorrhoid" affects the quality of life due to hemorrhage and prolapse as a common and frequently-occurring disease. Endoscopic sclerosing agent injection has replaced traditional surgery and become the most commonly used treatment method in developed countries. At present, how to reduce the side effects of sclerosing agent and accurately determine the injection site and depth has become a difficult clinical problem. The research group creatively put forward the theory of foam sclerosing agent to treat internal hemorrhoids in the early stage. With the aid of transparent cap, the visibility of surgical field of vision can be improved. The mini probe ultrasound (MPS) is proposed to effectively evaluate the submucosal in

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
700

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
      • Shanghai, China
        • Recruiting
        • Xinhua Hospital,Shangha Jiao Tong University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 66 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • People are willing to sign the informed consent form of this trial.
  • People(aged 18 to 70 years) with clinical symptoms such as bleedingprolapse and so on have been diagnosed with grade I, grade II and grade III internal hemorrhoids by colonic epdoscopy;
  • People can follow short-term (3 month) and long-term (12 month) visit plans;
  • Describe symptoms objectively and actively complete the evaluation scale;
  • No allergic diseases and allergy to sclerosing drugs;
  • Non-lactating and pregnant women: patients without pregnancy plan (including the men) in 1 month after the test;
  • Did not participate in any drug trials (including this trial drug) within 3 months before the trial;
  • People with long-term use of anticoagulant drugs (such as aspirin, clopidogrel, etc.) need to be stopped for 5-7 day

Exclusion Criteria:

  • People with severe insufficiency of heart, brain, lung and other organs, leading to inability to tolerate endoscopic treatment;
  • People with drug allergies or abnormal blood coagulation function;
  • People suffering from or combined with digestive tract diseases,such as the colon malignancyulcerative colitis or Crohn's diseaseacute diarrheaacute thrombotic internal hemorrhoids with painanal fistulaanal fissurefecal incontinence
  • Men with history of severe prostate hypertrop;
  • People with any reasons that the researchers believe can not be selected

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Foam sclerotherapy,FS
Participants in this arm will receive the enteroscopic treatment with the sclerosing foam of lauromacrogol.
Drug: Sclerosing foam of Lauromacrogol
Participants in FS will receive enteroscopy with the sclerosing foam of lauromacrogol.
Placebo Comparator: Liquid sclerotherapy,Ls
Participants in this arm will receive the enteroscopic treatment with the liquid of lauromacrogol.
Drug: Sclersing liqiud of Lauromacrogol
Participants in LS will receive enteroscopy with the sclerosing liquid of lauromacrogol.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
the condition of bleeding、perianal pruritus 、the degree of prolapse of internal hemorrhoids and the influence of internal hemorrhoids by self-assessment.
Time Frame: 12 months
After 12 months,all the participants will receive the telephone follow-up to record their self-assessment.
12 months
the condition of perianal pruritus、the description of hemorrhoids(include the number and depth of hemorrhoids)、the need for additiongal sclerotherapy under colonic endoscopy.
Time Frame: 12 months
after 12 months ,all the participants will receive the colonic endoscopy and we will record the degree of prolapse of internal hemorrhoids、the numbers of hemorrhoid under colonic endoscopy.
12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
the condition of participants' bleeding、perianal pain and perianal pruritus after the endoscopic treatment.
Time Frame: 1 day
one day after receiving endoscopic treatment , all the participants will receive the telephone follow-up and we will record their self-assessment,include the condition of bleeding、perianal pain and perianal pruritus.
1 day
the condition of bleeding、perianal pruritus 、the degree of prolapse of internal hemorrhoids and the influence of internal hemorrhoids by self-assessment.
Time Frame: 3 months
After 3 months,all the participants will receive the telephone follow-up to record their self-assessment.
3 months
the condition of participants' bleeding、perianal pain and perianal pruritus after the endoscopic treatment.
Time Frame: 1 week
one week after receiving endoscopic treatment , all the participants will receive the telephone follow-up and we will record their self-assessment,include the condition of bleeding、perianal pain and perianal pruritus.
1 week
the condition of perianal pruritus、the description of hemorrhoids(include the number and depth of hemorrhoids)、the need for additiongal sclerotherapy under colonic endoscopy.
Time Frame: 3 months
after 3 months ,all the participants will receive the colonic endoscopy and we will record the degree of prolapse of internal hemorrhoids、the numbers of hemorrhoid under colonic endoscopy.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
The First Affiliated Hospital of Zhengzhou University
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Anhui Provincial Hospital
Nanjing PLA General Hospital
Luoyang Central Hospital
Changzhi People's Hospital
Tongren Hospital,Shanghai Jiao Tong University School of Medicine
Shanghai Construction Group Hospital
Shandong Maternal and Chidl Care Service Center
West China Forth University Hospital，Sichuan University
The First Hospital of Anhui Medical University
Jiangsu Provincial Second Chinese Medicine Hospital
Ganzhou Fifth pepole's Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Leiming Xu, Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine
  • Principal Investigator: Yi Zhang, Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine
  • Principal Investigator: Zhenzhong Deng, Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine
  • Principal Investigator: Haixia Peng, Tong Ren Hospital affiliated to Shanghai Jiaotong University School of Medicine
  • Principal Investigator: Hui Pan, Shanghai Construction Group Hospital
  • Principal Investigator: Fengyu Gao, Shandong Maternal and Child Health Center affiliated to Shandong University
  • Principal Investigator: Hao Zhang, Baoshan People's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 15, 2020

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2020

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 9, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 18, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 21, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 21, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 18, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • XH-20-006

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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