Grade/Stage I HemorrhoidsPhase 4NCT04398823
A Multicenter Prospective Clinical Study of Endoscopic Foam Sclerotherapy for Internal Hemorrhoids
A Phase 4 study testing Sclerosing foam of Lauromacrogol and Sclersing liqiud of Lauromacrogol in people with Grade/Stage I Hemorrhoids and Prolapsed Grade II Internal Haemorrhoid, run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial summary
"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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Grade/Stage I Hemorrhoids, Prolapsed Grade II Internal Haemorrhoid, Prolapsed Grade III Internal Haemorrhoid
- What is being tested?
- Sclerosing foam of Lauromacrogol and Sclersing liqiud of Lauromacrogol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 700 participants
- Where
- 1 siteChina
- Study dates
- 15 May 2020to 31 Dec 2021
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Xinhua Hospital,Shangha Jiao Tong University
Shanghai
Feng Shen
About this study
"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
- Conditions
- Grade/Stage I Hemorrhoids, Prolapsed Grade II Internal Haemorrhoid, Prolapsed Grade III Internal Haemorrhoid
- Being tested
- Sclerosing foam of Lauromacrogol, Sclersing liqiud of Lauromacrogol
- Keywords
- hemorrhoids
- Medical subject headings
- Hemorrhoids
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sclerosing foam of LauromacrogolDrug
Participants in FS will receive enteroscopy with the sclerosing foam of lauromacrogol.
Sclersing liqiud of LauromacrogolDrug
Participants in LS will receive enteroscopy with the sclerosing liquid of lauromacrogol.
| Study group | Role | What they receive |
|---|---|---|
| Foam sclerotherapy,FS | Active comparator | Participants in this arm will receive the enteroscopic treatment with the sclerosing foam of lauromacrogol. Receives: Drug: Sclerosing foam of Lauromacrogol |
| Liquid sclerotherapy,Ls | Placebo comparator | Participants in this arm will receive the enteroscopic treatment with the liquid of lauromacrogol. Receives: Drug: Sclersing liqiud of Lauromacrogol |
What is being measured
The primary outcome is the main question the study is designed to answer.
the condition of bleeding、perianal pruritus 、the degree of prolapse of internal hemorrhoids and the influence of internal hemorrhoids by self-assessment.
After 12 months,all the participants will receive the telephone follow-up to record their self-assessment.
Measured: 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.
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.
Measured: 12 months
Secondary outcomes (4)
the condition of participants' bleeding、perianal pain and perianal pruritus after the endoscopic treatment.
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.
Measured: 1 day
the condition of bleeding、perianal pruritus 、the degree of prolapse of internal hemorrhoids and the influence of internal hemorrhoids by self-assessment.
After 3 months,all the participants will receive the telephone follow-up to record their self-assessment.
Measured: 3 months
the condition of participants' bleeding、perianal pain and perianal pruritus after the endoscopic treatment.
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.
Measured: 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.
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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2020
- Study start15 May 2020 (estimated)
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Grade/Stage I HemorrhoidsStudies of the same condition, open and under way.
- More trials run by Xinhua Hospital, Shanghai Jiao Tong University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 700 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Tong Ren Hospital, Shanghai Construction Group Hospital, Shandong Maternal and Chidl Care Service Center, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University, West China Fourth Hospital, The First Affiliated Hospital of Anhui Medical University, The First Affiliated Hospital of Zhengzhou University, Jiangsu Provincial Second Chinese Medicine Hospital, Anhui Provincial Hospital, Luoyang Central Hospital, Ganzhou Fifth pepole's Hospital, Changzhi People's Hospital, Nanjing PLA General Hospital
- Responsible party
- Sponsor
- Investigators
- Leiming Xu, Study chair, Xinhua Hospital, Shanghai Jiao Tong University School of MedicineYi Zhang, Principal investigator, Xinhua Hospital, Shanghai Jiao Tong University School of MedicineZhenzhong Deng, Principal investigator, Xinhua Hospital, Shanghai Jiao Tong University School of MedicineHaixia Peng, Principal investigator, Tong Ren Hospital affiliated to Shanghai Jiaotong University School of MedicineHui Pan, Principal investigator, Shanghai Construction Group HospitalFengyu Gao, Principal investigator, Shandong Maternal and Child Health Center affiliated to Shandong UniversityHao Zhang, Principal investigator, BaoShan People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04398823
- Sponsor's protocol ID
- XH-20-006
- Status last verified
- Apr 2020
- First submitted
- 9 May 2020
- Last updated
- 21 May 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Prospective Clinical Study of Endoscopic Foam Sclerotherapy for Internal Hemorrhoids
- ClinicalTrials.gov ID
- NCT04398823
- Acronym / sponsor ID
- XH-20-006
- Conditions
- Grade/Stage I Hemorrhoids, Prolapsed Grade II Internal Haemorrhoid, Prolapsed Grade III Internal Haemorrhoid
- Keywords
- hemorrhoids
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- Xinhua Hospital, Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Collaborators
- Shanghai Tong Ren Hospital, Shanghai Construction Group Hospital, Shandong Maternal and Chidl Care Service Center, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University, West China Fourth Hospital, The First Affiliated Hospital of Anhui Medical University, The First Affiliated Hospital of Zhengzhou University, Jiangsu Provincial Second Chinese Medicine Hospital, Anhui Provincial Hospital, Luoyang Central Hospital, Ganzhou Fifth pepole's Hospital, Changzhi People's Hospital, Nanjing PLA General Hospital
- Study start
- 15 May 2020 (estimated)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 21 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
"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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Foam sclerotherapy,FS | Active comparator | Drug: Sclerosing foam of LauromacrogolParticipants in this arm will receive the enteroscopic treatment with the sclerosing foam of lauromacrogol. |
| Liquid sclerotherapy,Ls | Placebo comparator | Drug: Sclersing liqiud of LauromacrogolParticipants in this arm will receive the enteroscopic treatment with the liquid of lauromacrogol. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sclerosing foam of LauromacrogolParticipants in FS will receive enteroscopy with the sclerosing foam of lauromacrogol. | Drug | Foam sclerotherapy,FS |
| Sclersing liqiud of LauromacrogolParticipants in LS will receive enteroscopy with the sclerosing liquid of lauromacrogol. | Drug | Liquid sclerotherapy,Ls |
Primary outcome
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.
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.
4 secondary outcomes
the condition of participants' bleeding、perianal pain and perianal pruritus after the endoscopic treatment.
Time frame: 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
the condition of participants' bleeding、perianal pain and perianal pruritus after the endoscopic treatment.
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Leiming Xu study chair
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Yi Zhang principal investigator
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Zhenzhong Deng principal investigator
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Sclerosing foam of Lauromacrogol and Sclersing liqiud of Lauromacrogol in people with Grade/Stage I Hemorrhoids and Prolapsed Grade II Internal Haemorrhoid, run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Feng Shen (18202159980, shenfeng01@xinhuamed.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2020.