HemorrhoidsNCT05228054
Treatment of Hemorrhoid With 1940nm Laser Procedure
A study testing laser procedure and sclerotherapy in people with Hemorrhoids, run by State Scientific Centre of Coloproctology, Russian Federation at 1 site in Russia.
Trial summary
Patients with hemorrhoids 2-3 st will be treated with laser 1940nm or sclerothearapy with Aethoxysklerol Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hemorrhoids
- What is being tested?
- laser procedure and sclerotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteRussia
- Study dates
- 26 Jan 2021to 30 Aug 2024
- Phase
- Interventional
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- hemorrhoids 2-3st
Who cannot join
- Acute hemorrhoids IBD psychosomatic diseases previous surgical interventions
Trial locations and contacts
1 site in 1 country.
Russia1 site, 1 recruiting
- Recruiting
State Scientific Centre of Coloproctology
Moscow, 123423
Sergey Achkasov, MD, +7-495-199-6783, info@gnck.ru
Vyacheslav Korolik, PhD
About this study
Patients with hemorrhoids 2-3 st will be treated with laser 1940nm or sclerothearapy with Aethoxysklerol
Read the detailed description
Prospective randomized, control study. Patients with hemorrhoids 2-3 will be randomized in two groups. 100 patient in each. Patients will be treated with laser 1940nm or sclerothearapy with Aethoxysklerol.
Follow up for one year. Primary end point - recurrence of hemorrhoids desease.
- Conditions
- Hemorrhoids
- Being tested
- laser procedure, sclerotherapy
- Keywords
- hemorrhoids, laser, sclerotherapy
- Medical subject headings
- Hemorrhoids
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laser procedureProcedure or surgery
In modified litothomy position patients with hemorrhoidal deasease will be treated with transcutaneous laser 1940nm 3watt in impulse regimen
sclerotherapyProcedure or surgery
In modified litothomy position patients with hemorrhoidal deasease will be treated with sclerotherapy with Aethoxysklerol
| Study group | Role | What they receive |
|---|---|---|
| Laser 1940nm | Experimental | Patients with hemorrhoidal deasease 2-3 st. who will be treated with laser 1940nm Receives: Procedure: laser procedure |
| sclerotherapy | Active comparator | Patients with hemorrhoidal deasease 2-3 st. who will be treated with sclerotherapy Receives: Procedure: sclerotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reccurence rate
reccurence of hemorroids desease
Measured: 12 months
Secondary outcomes (2)
Pain intensity
Score representing patient's current pain intensity
Minimum: 0 (no pain) Maximum: 100 (very severe pain)
Measured: 7 days
QoL
The SF-36 is often used as a measure of a person or population's quality of life (QOL) The SF-36 has eight scaled scores; the scores are weighted sums of the questions in each section. Scores range from 0 - 100 Lower scores = more disability, higher scores = less disability
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2022
- Study start26 Jan 2021
- Primary completion30 Dec 2023 (estimated)
- Study completion30 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemorrhoidsStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients with hemorrhoids 2-3st will be randomized in two groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- State Scientific Centre of Coloproctology, Russian Federation
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05228054
- Sponsor's protocol ID
- 34
- Status last verified
- Feb 2022
- First submitted
- 26 Jan 2022
- Last updated
- 8 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Hemorrhoid With 1940nm Laser Procedure
- ClinicalTrials.gov ID
- NCT05228054
- Acronym / sponsor ID
- 34
- Conditions
- Hemorrhoids
- Keywords
- hemorrhoids, laser, sclerotherapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- State Scientific Centre of Coloproctology, Russian FederationOther government
- Study start
- 26 Jan 2021 (actual)
- Primary completion
- 30 Dec 2023 (estimated)
- Study completion
- 30 Aug 2024 (estimated)
- First posted
- 8 Feb 2022 (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.
Patients with hemorrhoids 2-3 st will be treated with laser 1940nm or sclerothearapy with Aethoxysklerol
Detailed description
Prospective randomized, control study. Patients with hemorrhoids 2-3 will be randomized in two groups. 100 patient in each. Patients will be treated with laser 1940nm or sclerothearapy with Aethoxysklerol.
Follow up for one year. Primary end point - recurrence of hemorrhoids desease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Patients with hemorrhoids 2-3st will be randomized in two groups
| Arm | Type | Receives |
|---|---|---|
| Laser 1940nm | Experimental | Procedure: laser procedurePatients with hemorrhoidal deasease 2-3 st. who will be treated with laser 1940nm |
| sclerotherapy | Active comparator | Procedure: sclerotherapyPatients with hemorrhoidal deasease 2-3 st. who will be treated with sclerotherapy |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- hemorrhoids 2-3st
Key exclusion criteria (1 listed)
- Acute hemorrhoids IBD psychosomatic diseases previous surgical interventions
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 |
|---|---|---|
| laser procedureIn modified litothomy position patients with hemorrhoidal deasease will be treated with transcutaneous laser 1940nm 3watt in impulse regimen | Procedure or surgery | Laser 1940nm |
| sclerotherapyIn modified litothomy position patients with hemorrhoidal deasease will be treated with sclerotherapy with Aethoxysklerol | Procedure or surgery | sclerotherapy |
Primary outcome
Reccurence rate
Time frame: 12 months
reccurence of hemorroids desease
2 secondary outcomes
Pain intensity
Time frame: 7 days
QoL
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2022.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing laser procedure and sclerotherapy in people with Hemorrhoids, run by State Scientific Centre of Coloproctology, Russian Federation at 1 site in Russia.
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 1 inclusion and 1 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 8 Feb 2022. 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 Russia. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reccurence rate (time frame: 12 months). 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 8 Feb 2022.