A Phase 4 interventional study of Standardized 3% Polidocanol Foam Sclerotherapy in Internal Piles Sclerotherapy and Internal Hemorrhoids, sponsored by Radwa Hussein Mohammed Hasanen. Not yet recruiting. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-10-08.
Sponsored by Radwa Hussein Mohammed Hasanen · Phase 4, Interventional, and Treatment
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.
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 .
238 studies on the registry are indexed under Hemorrhoids; 73 are open to participants now.
This study's planned enrollment of 130 is above the median of 100 across 183 interventional studies indexed under Hemorrhoids.
Browse Hemorrhoids studies →This is the only study on the registry with Radwa Hussein Mohammed Hasanen as lead sponsor.
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Exclusion Criteria:
Inability to complete follow-up.
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Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
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An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
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Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
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Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Procedure: Standardized 3% Polidocanol Foam Sclerotherapy
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
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.
Time frame: 12 months follow up
No study locations are listed for this record.
Plan to share: No
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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