Internal Piles SclerotherapyPhase 4NCT07866248
Evaluation of Polidocanol Foam Sclerotherapy in Symptomatic Internal Hemorrhoids: A Prospective Study
A Phase 4 study testing Standardized 3% Polidocanol Foam Sclerotherapy in people with Internal Piles Sclerotherapy and Internal Hemorrhoids, run by Radwa Hussein Mohammed Hasanen.
Trial summary
To evaluate the efficacy, durability, safety, and clinical/endoscopic outcomes of standardized 3% polidocanol foam sclerotherapy in patients with symptomatic grade II-III internal hemorrhoids over a 12-month follow-up period. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Internal Piles Sclerotherapy, Internal Hemorrhoids
- What is being tested?
- Standardized 3% Polidocanol Foam Sclerotherapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2026to 1 Sep 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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
- Age ≥18 years.
- Symptomatic internal hemorrhoidal disease.
- Goligher grade II or III hemorrhoids.
- Predominant hemorrhoidal bleeding (>or equal 2 episodes of rectal bleeding/ week in last 4 weeks) and/or prolapse.
- Persistent symptoms despite 4 to 6 weeks of conservative treatment (high fibers diet 25/30 g/day, increase water intake, avoid straining, stool softening and topical treatment as anesthetics and corticosteroids containing preparations) .
- Suitable for outpatient Polidocanol foam sclerotherapy treatment.
- Willingness to comply with the study protocol.
Who cannot join
- Goligher grade IV hemorrhoids.
- Predominantly external hemorrhoidal disease.
- Acute thrombosed hemorrhoids.
- Active anorectal infection.
- Anal fissure or fistula responsible for presenting symptoms.
- Known colorectal malignancy.
Show all 15Show fewer
- Active inflammatory bowel disease involving the anorectal region.
- Uncorrected bleeding disorder.
- Known hypersensitivity to polidocanol.
- Previous hemorrhoidal surgery substantially altering anorectal anatomy.
- Severe uncontrolled systemic illness preventing the procedure.
- Pregnancy where treatment is considered inappropriate according to institutional policy.
- Inability to provide informed consent.
- Inability to complete follow-up.
- -
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
To evaluate the efficacy, durability, safety, and clinical/endoscopic outcomes of standardized 3% polidocanol foam sclerotherapy in patients with symptomatic grade II-III internal hemorrhoids over a 12-month follow-up period.
Read the detailed description
Hemorrhoidal disease (HD) affects approximately 4% of the population . Its management is typically guided by the Goligher classification and the impact of symptoms on the patient's quality of life. While grade IV HD is usually treated with surgical excision, lower-grade cases can often be managed with less invasive techniques, including office-based procedures such as sclerotherapy and rubber band ligation (RBL), when conservative treatments fail. Sclerotherapy dates back to the nineteenth century as the first minimally invasive treatment described for HD .
Polidocanol (hydroxy-polyethoxy-dodecane) is a synthetic long-chain fatty alcohol, was first used as a sclerosing agent in Germany in the 1960s. polidicanol can be used in treatment of spider veins, reticular veins, varicose veins and hemorrhoids .
Polidocanol works as detergent that cause endothelial destruction and thrombosis, induce sterile inflammation so result in fibrosis and tissue atrophy with vascular obliteration shrinkage and fixation of hemorrhodal cushion so reduction of bleeding and prolapse.
More recently, polidocanol has emerged as a sclerosing agent, first gaining widespread use in the treatment of varicose veins, before being successfully applied to HD. Its improved safety profile progressively replaced phenol oil as the preferred sclerosing agent, and the introduction of polidocanol foam further enhanced its efficacy compared to the original liquid formulation .
The use of polidocanol in foam form has gained attention owing to its practical advantages, including cost-effectiveness, less pain, fewer required office-based sessions, rapid recovery as patient can return to normal activity next day and lower incidence of bleeding complications so suitable for patients with bleeding disorders.
These advancements have led to a shifting paradigm, with sclerotherapy increasingly being considered a first-line treatment for symptomatic grade II-III HD, potentially reserving RBL for recurrent cases .
- Conditions
- Internal Piles Sclerotherapy, Internal Hemorrhoids
- Being tested
- Standardized 3% Polidocanol Foam Sclerotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standardized 3% Polidocanol Foam SclerotherapyProcedure or surgery
3% polidocanol foam, Sims position, Open-ended anoscope, use of 20-G needle, Injection above dentate line, Intra-pile injection, 2 ml foam / symptomatic hemorrhoidal cushion, Maximum 3 cushions / session, Maximum plained study dose 6 ml foam / session , Assessment at 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| 3% polidocanol foam injection in internal hemorrhoids for sclerotherapy | Active comparator | 3% polidocanol foam, Sims position, Open-ended anoscope, use of 20-G needle, Injection above dentate line, Intra-pile injection, 2 ml foam / symptomatic hemorrhoidal cushion, Maximum 3 cushions / session, Maximum plained study dose 6 ml foam / session , Assessment at 4 weeks Receives: Procedure: Standardized 3% Polidocanol Foam Sclerotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sustained treatment success at 12 months
A patient will be classified as having sustained treatment success if at 12 months all of the following are satisfied: clinically meaningful improvement from baseline; no clinically significant recurrent bleeding; no persistent clinically significant prolapse requiring regular manual reduction; no need for surgical hemorrhoidectomy; no need for another hemorrhoidal intervention beyond the protocolized maximum of two PFS sessions; and satisfactory patient-reported outcome.
Measured: 12 months follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2026
- Study start1 Oct 2026 (estimated)
- Primary completion1 Jun 2028 (estimated)
- Study completion1 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Internal Piles SclerotherapyStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Radwa Hussein Mohammed Hasanen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Radwa Hussein Mohammed Hasanen, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07866248
- Sponsor's protocol ID
- Polidocanol in internal piles
- Status last verified
- Oct 2026
- First submitted
- 4 Oct 2026
- Last updated
- 8 Oct 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gallo G, Grossi U, De Simone V, Picciariello A, Diaco E, Fan P, He H, Li J, Lin H, La Torre M, Laforgia R, Lobascio P, Ma H, Pata F, Perinotti R, De Parades V, Pozzo M, Realis Luc A, Salgueiro P, Skowronski A, Sun P, Trompetto M, Tutino R, Wang C, Wang Z, Wang Z, Wu J, Zhang Y, Zhao S, Zeng X, Fernandes V, Moser KH, Ren D, Sileri P, Gravante G. Real-world use of polidocanol foam sclerotherapy for hemorrhoidal disease: insights from an international survey and systematic review with clinical practice recommendations. Updates Surg. 2025 Sep;77(5):1439-1450. doi: 10.1007/s13304-025-02258-2. Epub 2025 Jun 6.
PubMed 40481245Fernandes V, Fonseca J. Polidocanol Foam Injected at High Doses with Intravenous Needle: The (Almost) Perfect Treatment of Symptomatic Internal Hemorrhoids. GE Port J Gastroenterol. 2019 May;26(3):169-175. doi: 10.1159/000492202. Epub 2018 Aug 31.
PubMed 31192285Qu CY, Zhang FY, Wang W, Gao FY, Lin WL, Zhang H, Chen GY, Zhang Y, Li MM, Li ZH, Cai MH, Xu LM, Shen F. Endoscopic polidocanol foam sclerobanding for the treatment of grade II-III internal hemorrhoids: A prospective, multi-center, randomized study. World J Gastroenterol. 2024 Jul 21;30(27):3326-3335. doi: 10.3748/wjg.v30.i27.3326.
PubMed 39086750
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Polidocanol Foam Sclerotherapy in Symptomatic Internal Hemorrhoids: A Prospective Study
- ClinicalTrials.gov ID
- NCT07866248
- Acronym / sponsor ID
- Polidocanol in internal piles
- Conditions
- Internal Piles Sclerotherapy, Internal Hemorrhoids
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Radwa Hussein Mohammed HasanenUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 1 Jun 2028 (estimated)
- Study completion
- 1 Sep 2028 (estimated)
- First posted
- 8 Oct 2026 (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.
To evaluate the efficacy, durability, safety, and clinical/endoscopic outcomes of standardized 3% polidocanol foam sclerotherapy in patients with symptomatic grade II-III internal hemorrhoids over a 12-month follow-up period.
Detailed description
Hemorrhoidal disease (HD) affects approximately 4% of the population . Its management is typically guided by the Goligher classification and the impact of symptoms on the patient's quality of life. While grade IV HD is usually treated with surgical excision, lower-grade cases can often be managed with less invasive techniques, including office-based procedures such as sclerotherapy and rubber band ligation (RBL), when conservative treatments fail. Sclerotherapy dates back to the nineteenth century as the first minimally invasive treatment described for HD .
Polidocanol (hydroxy-polyethoxy-dodecane) is a synthetic long-chain fatty alcohol, was first used as a sclerosing agent in Germany in the 1960s. polidicanol can be used in treatment of spider veins, reticular veins, varicose veins and hemorrhoids .
Polidocanol works as detergent that cause endothelial destruction and thrombosis, induce sterile inflammation so result in fibrosis and tissue atrophy with vascular obliteration shrinkage and fixation of hemorrhodal cushion so reduction of bleeding and prolapse.
More recently, polidocanol has emerged as a sclerosing agent, first gaining widespread use in the treatment of varicose veins, before being successfully applied to HD. Its improved safety profile progressively replaced phenol oil as the preferred sclerosing agent, and the introduction of polidocanol foam further enhanced its efficacy compared to the original liquid formulation .
The use of polidocanol in foam form has gained attention owing to its practical advantages, including cost-effectiveness, less pain, fewer required office-based sessions, rapid recovery as patient can return to normal activity next day and lower incidence of bleeding complications so suitable for patients with bleeding disorders.
These advancements have led to a shifting paradigm, with sclerotherapy increasingly being considered a first-line treatment for symptomatic grade II-III HD, potentially reserving RBL for recurrent cases .
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 3% polidocanol foam injection in internal hemorrhoids for sclerotherapy | Active comparator | Procedure: Standardized 3% Polidocanol Foam Sclerotherapy3% polidocanol foam, Sims position, Open-ended anoscope, use of 20-G needle, Injection above dentate line, Intra-pile injection, 2 ml foam / symptomatic hemorrhoidal cushion, Maximum 3 cushions / session, Maximum plained study dose 6 ml foam / session , Assessment at 4 weeks |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥18 years.
- Symptomatic internal hemorrhoidal disease.
- Goligher grade II or III hemorrhoids.
- Predominant hemorrhoidal bleeding (>or equal 2 episodes of rectal bleeding/ week in last 4 weeks) and/or prolapse.
- Persistent symptoms despite 4 to 6 weeks of conservative treatment (high fibers diet 25/30 g/day, increase water intake, avoid straining, stool softening and topical treatment as anesthetics and corticosteroids containing preparations) .
Key exclusion criteria (15 listed)
- Goligher grade IV hemorrhoids.
- Predominantly external hemorrhoidal disease.
- Acute thrombosed hemorrhoids.
- Active anorectal infection.
- Anal fissure or fistula responsible for presenting symptoms.
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 |
|---|---|---|
| Standardized 3% Polidocanol Foam Sclerotherapy3% polidocanol foam, Sims position, Open-ended anoscope, use of 20-G needle, Injection above dentate line, Intra-pile injection, 2 ml foam / symptomatic hemorrhoidal cushion, Maximum 3 cushions / session, Maximum plained study dose 6 ml foam / session , Assessment at 4 weeks | Procedure or surgery | 3% polidocanol foam injection in internal hemorrhoids for sclerotherapy |
Primary outcome
Sustained treatment success at 12 months
Time frame: 12 months follow up
A patient will be classified as having sustained treatment success if at 12 months all of the following are satisfied: clinically meaningful improvement from baseline; no clinically significant recurrent bleeding; no persistent clinically significant prolapse requiring regular manual reduction; no need for surgical hemorrhoidectomy; no need for another hemorrhoidal intervention beyond the protocolized maximum of two PFS sessions; and satisfactory patient-reported outcome.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2026.
- Results publication: PubMed 40481245Gallo G, Grossi U, De Simone V, Picciariello A, Diaco E, Fan P, He H, Li J, Lin H, La Torre M, Laforgia R, Lobascio P, Ma H, Pata F, Perinotti R, De Parades V, Pozzo M, Realis Luc A, Salgueiro P, Skowronski A, Sun P, Trompetto M, Tutino R, Wang C, Wang Z, Wang Z, Wu J, Zhang Y, Zhao S, Zeng X, Fernandes V, Moser KH, Ren D, Sileri P, Gravante G. Real-world use of polidocanol foam sclerotherapy for hemorrhoidal disease: insights from an international survey and systematic review with clinical practice recommendations. Updates Surg. 2025 Sep;77(5):1439-1450. doi: 10.1007/s13304-025-02258-2. Epub 2025 Jun 6.
- Results publication: PubMed 31192285Fernandes V, Fonseca J. Polidocanol Foam Injected at High Doses with Intravenous Needle: The (Almost) Perfect Treatment of Symptomatic Internal Hemorrhoids. GE Port J Gastroenterol. 2019 May;26(3):169-175. doi: 10.1159/000492202. Epub 2018 Aug 31.
- Results publication: PubMed 39086750Qu CY, Zhang FY, Wang W, Gao FY, Lin WL, Zhang H, Chen GY, Zhang Y, Li MM, Li ZH, Cai MH, Xu LM, Shen F. Endoscopic polidocanol foam sclerobanding for the treatment of grade II-III internal hemorrhoids: A prospective, multi-center, randomized study. World J Gastroenterol. 2024 Jul 21;30(27):3326-3335. doi: 10.3748/wjg.v30.i27.3326.
- Individual participant dataSharing planned: No
Related trials for Internal Piles Sclerotherapy
RecruitingObservational study
CAES for Internal Hemorrhoids and Rectal Prolapse
Internal Hemorrhoid, Rectal Prolapse
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.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Standardized 3% Polidocanol Foam Sclerotherapy in people with Internal Piles Sclerotherapy and Internal Hemorrhoids, run by Radwa Hussein Mohammed Hasanen.
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 7 inclusion and 15 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: opening soon, as of the sponsor's last update on 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
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.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Radwa Hussein Mohammed, Assistant lecturer at Assuit U (01008056779, radwahmohammed93@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sustained treatment success at 12 months (time frame: 12 months follow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07866248, which also lists 3 linked publications.
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 Oct 2026.