Chronic Anal FissureNCT04793347
Effect of Shock Waves Therapy on Chronic Anal Fissure
A study testing shock master (shock waves device) in people with Chronic Anal Fissure, run by amr bayoumi salama at 1 site in Egypt.
Trial summary
the study conducted to assess if there is an effect of Extracorporeal Shock Wave Treatment on anal fissure Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Anal Fissure
- What is being tested?
- shock master (shock waves device)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Mar 2021to 30 May 2021
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- patient with chronic anal fissure
- symptomatic for at least 6 months
- failed conservative measures
Who cannot join
- Pregnant women,
- cardiac patients,
- patients with a pacemaker,
- low molecular heparin or warfarin treatment,
- neurological disease,
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Shock Waves Therapy on Anal Fissure
the study conducted to assess if there is an effect of Extracorporeal Shock Wave Treatment on anal fissure
Read the detailed description
Design of the study:
A prospective, randomized, blind, paired (right/left) comparison.
Materials:
Measurement tool:
- healing of anal fissure,
- Wexner Constipation Scoring System
- anal pain intensity by means of a 10-point visual analogue scale (VAS)
Therapeutic instruments:
•. shock waves
- topical application of 0.4% glyceryl trinitrate (GTN) ointment
Methods:
- Testing procedures: The assessment will be performed before commencing treatment, after 4 and 8 weeks of the treatment.
- Treatment procedures: Patients will be assigned randomly into two groups equal in number: shock waves Group: twenty patients will receive the shockwaves on perianal area of for 4 weeks (3 sessions /week). control Group: twenty patients will receive the recommended routine medical treatment include topical application of 0.4% glyceryl trinitrate (GTN) ointment only..
- Conditions
- Chronic Anal Fissure
- Being tested
- shock master (shock waves device)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
shock master (shock waves device)Device
device produces shock waves
| Study group | Role | What they receive |
|---|---|---|
| shock waves | Experimental | group of patients with anal fissure will be treated with shock waves Receives: Device: shock master (shock waves device) |
What is being measured
The primary outcome is the main question the study is designed to answer.
VAS
assessment of pain
Measured: up to 3 months
Secondary outcomes (1)
wexener scale
assess the constipation
Measured: up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2021
- Study start10 Mar 2021 (estimated)
- Primary completion30 Apr 2021 (estimated)
- Study completion30 May 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Anal FissureStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- amr bayoumi salama
- Sponsor type
- University, hospital or other
- Collaborators
- Cairo University
- Responsible party
- Sponsor-investigator, amr bayoumi salama, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04793347
- Sponsor's protocol ID
- nu5332
- Status last verified
- Mar 2021
- First submitted
- 6 Mar 2021
- Last updated
- 11 Mar 2021
- 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 11 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Shock Waves Therapy on Anal Fissure
- ClinicalTrials.gov ID
- NCT04793347
- Acronym / sponsor ID
- nu5332
- Conditions
- Chronic Anal Fissure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- amr bayoumi salamaUniversity, hospital or other
- Collaborators
- Cairo University
- Study start
- 10 Mar 2021 (estimated)
- Primary completion
- 30 Apr 2021 (estimated)
- Study completion
- 30 May 2021 (estimated)
- First posted
- 11 Mar 2021 (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.
the study conducted to assess if there is an effect of Extracorporeal Shock Wave Treatment on anal fissure
Detailed description
Design of the study:
A prospective, randomized, blind, paired (right/left) comparison.
Materials:
Measurement tool:
- healing of anal fissure,
- Wexner Constipation Scoring System
- anal pain intensity by means of a 10-point visual analogue scale (VAS)
Therapeutic instruments:
•. shock waves
- topical application of 0.4% glyceryl trinitrate (GTN) ointment
Methods:
- Testing procedures: The assessment will be performed before commencing treatment, after 4 and 8 weeks of the treatment.
- Treatment procedures: Patients will be assigned randomly into two groups equal in number: shock waves Group: twenty patients will receive the shockwaves on perianal area of for 4 weeks (3 sessions /week). control Group: twenty patients will receive the recommended routine medical treatment include topical application of 0.4% glyceryl trinitrate (GTN) ointment only..
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| shock waves | Experimental | Device: shock master (shock waves device)group of patients with anal fissure will be treated with shock waves |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- patient with chronic anal fissure
- symptomatic for at least 6 months
- failed conservative measures
Key exclusion criteria (5 listed)
- Pregnant women,
- cardiac patients,
- patients with a pacemaker,
- low molecular heparin or warfarin treatment,
- neurological disease,
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 |
|---|---|---|
| shock master (shock waves device)device produces shock waves | Device | shock waves |
Primary outcome
VAS
Time frame: up to 3 months
assessment of pain
1 secondary outcome
wexener scale
Time frame: up to 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing shock master (shock waves device) in people with Chronic Anal Fissure, run by amr bayoumi salama at 1 site in Egypt.
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 3 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 11 Mar 2021. 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 Egypt. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VAS (time frame: up to 3 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 11 Mar 2021.