Clinical trial · Interventional
Function Following Laser for Anal Intraepithelial Neoplasia (FLAN)
NCT04109573CI-TRIAL-00053600FLANunknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
High-grade squamous intraepithelial lesions (HSIL) and anal cancer are rising in incidence and at highest risk are HIV positive men who have sex with men (MSM). This pilot study assessing anal function and patient-reported outcomes before and after laser ablation of HSIL will add to the evidence that such a therapy is an acceptable and safe treatment to offer in a preventative setting.We will be recruting HIV positive and negative MSM.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anal Intraepithelial Neoplasia | Anal Intraepithelial Neoplasia | ONTOLOGY_EXACT | 0.98 |
| Anus Cancer | — | UNRESOLVED | — |
| Fecal Incontinence | — | UNRESOLVED | — |
| Post Operative Pain | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| high resolution anal manometry | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Anorectal function post anal laser
- description
- Intervention: Device: laser
- interventionNames
- Procedure: high resolution anal manometry
Primary outcomes (1)
- measure
- Manometric indices
- timeFrame
- Six months
- description
- Changes in pressure vailues - resting pressure and maximum squeeze pressure compared to patient's own pre treatment values
Secondary outcomes (4)
- measure
- Anal mucosal sensitivity
- timeFrame
- 6 months
- description
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: MSM \>18 years of age if HIV positive, CD4 count of over 350; if less, been on highly active antiretroviral treatment for at least 3 months Histologically proven high-grade squamous anal intraepithelial neoplasia lesion (HSIL) Anal canal disease with or without perianal disease Written informed consent Exclusion Criteria: Previous laser or other ablative treatment for HSIL (previous topical treatment is not excluded) Any treatment for HSIL in the previous six months Previous or current diagnosis of anal cancer Concurrent or previous (if severe) perianal inflammatory bowel disease, complex fistula or other significant perianal condition requiring surgery including fissures, current fistula in ano and Grade III or IV haemorrhoids Perianal sepsis Perianal disease only without anal canal HSIL
References
Publications (0)
Data not yet available
No reference posted for this study.