A prospective, single-arm, multicenter, real-world, post-market clinical follow-up study to evaluate the safety and performance of Mirus Hemorrhoidal Circular Stapler

Study Name:A prospective, single-arm, multicenter, real-world, post- market clinical follow-up study to evaluate the safety and performance of Mirus Hemorrhoidal Circular Stapler.

Short Title:Mirus Hemorrhoidal Circular Stapler

Protocol ID, Version & Date:MES/MIRUS HEMORRHOIDAL CIRCULAR STAPLER -

1_Version 1.0.0_01-Aug-2025

Study Device:Mirus™ Hemorrhoidal Circular Stapler

**Indication:**Mirus™ Hemorrhoidal Circular Stapler has application throughout the anal canal to perform surgical treatment of hemorrhoidal disease.

Contraindication: Do not use Mirus™ Hemorrhoidal Circular Stapler for Prolapse and Hemorrhoids where the compressed tissue thickness is less than 0.75 mm or greater than 1.5 mm or where the rectum internal diameter will not accommodate the instrument and accessories. If the instrument is used on tissue less than 0.75 mm or greater than 1.5 mm thick, it may result in staple malformation or hemorrhage.

2. Do not use Mirus™ Hemorrhoidal Circular Stapler for Prolapse and Hemorrhoids when anal stenosis exists.

3.Do not use Mirus™ Hemorrhoidal Circular Stapler for Prolapse and Hemorrhoids when severe mucosal edema exists.

4. Do not use Mirus™ Hemorrhoidal Circular Stapler for Prolapse and Hemorrhoids when severe fibrosis of hemorrhoid tissue exists.

5. Do not use Mirus™ Hemorrhoidal Circular Stapler for Prolapse and Hemorrhoids when tissue has undergone multiple injections of a hardening agent at hemorrhoids.

6. Do not use Mirus™ Hemorrhoidal Circular Stapler for Prolapse and Hemorrhoids on the participants undergoing anti coagulation therapy.

7.Mirus™ Hemorrhoidal Circular Stapler should not be used to staple necrotic, friable tissues or have altered integrity, e.g., ischemic or edematous tissues.

**Objective:**The study aims to evaluate the safety and performance of Mirus™ Hemorrhoidal Circular Stapler.

Hemorrhoidal disease is one of the most common conditions identified in outpatient clinics, resulting in 3.3 million outpatient visits annually in the U.S., with a self-reported incidence of 10 million cases per year, affecting 4.4% of the population

Currently, treatment options for hemorrhoidal disease (HD) range from conservative approaches, such as dietary changes and medications, to non-excisional methods like cryotherapy, sclerotherapy, laser photocoagulation, and rubber band ligation. For advanced cases, particularly grade III or IV hemorrhoids, or when conservative treatments fail in patients with persistent bleeding, surgical excision may be necessary .

Surgery is the most effective treatment for hemorrhoids and is particularly recommended for grade IV hemorrhoids (irreducible) and prolapsing hemorrhoids during defecation that may be manually reduced .

Traditional hemorrhoidal surgery, including Ferguson’s and Milligan-Morgan procedures, effectively removes hemorrhoids but causes significant postoperative pain due to external wounds. Stapled hemorrhoidopexy, introduced by Longo, has gained widespread acceptance for causing less pain and enabling faster recovery. This technique utilizes a specially designed circular stapling device that differs from traditional circular staplers used for creating full-thickness anastomoses .

Pain is the most common complication following hemorrhoidectomy procedures. Long-term complications include anal fissure, anal stenosis, incontinence, fistula, and hemorrhoidal recurrence. The significant pain associated with hemorrhoidectomies represents a major clinical concern .

The recently introduced laser hemorrhoidoplasty technique has been successfully applied to patients with hemorrhoids of all degrees. This method delivers laser energy into the interstitial tissue rather than the perianal vessels, resulting in tissue retraction and hemorrhoidal resolution. The technique produces less intense, shorter-duration pain and achieves satisfactory long-term outcomes. The distinctive feature of laser hemorrhoidoplasty is that the coagulated area remains invisible during the procedure since it lies beneath the healthy, uninjured mucosal layer.