NCT04981600 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Eddama MMR, Everson M, Renshaw S, Taj T, Boulton R, Crosbie J, Cohen CR
Radiofrequency ablation for the treatment of haemorrhoidal disease: a minimally invasive and effective treatment modality. Tech Coloproctol. 2019 Aug;23(8):769-774. doi: 10.1007/s10151-019-02054-2. Epub 2019 Aug 9.
Giamundo P, Salfi R, Geraci M, Tibaldi L, Murru L, Valente M
The hemorrhoid laser procedure technique vs rubber band ligation: a randomized trial comparing 2 mini-invasive treatments for second- and third-degree hemorrhoids. Dis Colon Rectum. 2011 Jun;54(6):693-8. doi: 10.1007/DCR.0b013e3182112d58. Erratum In: Dis Colon Rectum. 2012 Apr;55(4):497.
Maloku H, Gashi Z, Lazovic R, Islami H, Juniku-Shkololli A
Laser Hemorrhoidoplasty Procedure vs Open Surgical Hemorrhoidectomy: a Trial Comparing 2 Treatments for Hemorrhoids of Third and Fourth Degree. Acta Inform Med. 2014 Dec;22(6):365-7. doi: 10.5455/aim.2014.22.365-367. Epub 2014 Dec 19.
Pucher PH, Qurashi M, Howell AM, Faiz O, Ziprin P, Darzi A, Sodergren MH
Development and validation of a symptom-based severity score for haemorrhoidal disease: the Sodergren score. Colorectal Dis. 2015 Jul;17(7):612-8. doi: 10.1111/codi.12903.
Riss S, Weiser FA, Schwameis K, Riss T, Mittlbock M, Steiner G, Stift A
The prevalence of hemorrhoids in adults. Int J Colorectal Dis. 2012 Feb;27(2):215-20. doi: 10.1007/s00384-011-1316-3. Epub 2011 Sep 20.

Radiofrequency Ablation vs. Laser Hemorrhoidoplasty Procedure for Grade II-III Hemorrhoidal Disease: Prospective Randomised Controlled Trial

Clinical trial NCT04981600 - References