Study of MIRUSâ„¢ Disposable Hemorrhoids Stapler used in surgery during the treatment of prolapsed Hemorrhoids (Piles) to evaluate safety and efficacy of the device in post marketing period.

Not Applicable

Recruiting

• Conditions: Medical and Surgical,

• Registration Number: CTRI/2017/05/008476
• Lead Sponsor: Meril Endo Surgery Pvt Ltd

Brief Summary

This is a prospective, open-label, single-arm, multi-center, post marketing surveillance study to evaluate safety and performance of MIRUSâ„¢ Disposable Hemorrhoids Stapler in the treatment of prolapsed Hemorrhoids in minimum 80 subjects in India at approximately 5-10 centers.

The objective of the study is to evaluate safety and performance of Hemorrhoids Stapler for immediate and short-term postoperative outcomes at different time points [Time Frame: at Baseline, post procedure,15 days (±7 days), 3 months (±28 days) and 6 months (±28 days)].

All eligible subjects based on inclusion/exclusion will be approached to sign Informed Consent Form (ICF) approved by respective Ethics Committee (EC) before starting the study related process. The subjects will be treated using MIRUS Hemorrhoids Stapler for prolapsed hemorrhoids as per the standard guidelines and practices. The subject will be kept on a standard regimen in post-operative and follow-up period. Subject’s clinical follow-up will be taken at 15 days (±7 days), 3 months (±28 days), 6 months (±28 days).

Detailed Description

Not available

Study Timeline

• Study Start: 2017-08-05
• Last Update Posted: 2019-09-16

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• Each potential subject must satisfy all of the following criteria to be enrolled in the study: 1.
• Male and female subjects who are 18 to 80 years of age.
• Those subjects with late grade II hemorrhoids and unlikely to respond to one or two sessions of rubber band ligation (RBL) and/or conservative treatment.
• Subjects with grade III (prolapsing internal hemorrhoids requiring manual reduction) and/or grade IV (irreducible prolapse) are suitable candidate with stapled hemorrhoidopexy.
• Subject must sign an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study.
• Subject must follow the post-operative follow-up visits for 6 months.

Exclusion Criteria

• Any potential subject who meets any of the following criteria will be excluded from participating in the study: 1.
• Any female subject, who is pregnant, suspected pregnancy at the time of screening.
• Subject’s tissue thickness found to be less than 0.75mm or greater then 1.5mm, or where the internal diameter of the rectum will not be able to accommodate the instrument and accessories.
• Subject’s tissue has undergone multiple injections of hardening agent at hemorrhoids.
• The subject has a history of fecal incontinence.
• The subject has an active or a history of infection requiring antibiotics at the intended operative site within 30 days prior to the planned surgery date.
• The subject has a history of venous thrombosis or pulmonary embolism.
• The subject has a history of coagulopathy.
• The subject has taken aspirin, anti coagulation and/or anti platelet therapies (e.g. Warfarin, Lovenox) within 7 days prior to the planned date of surgery.
• The subject has existing anal stenosis/severe mucosal edema or any other co-morbidities which in the opinion of the investigator will not be appropriate for the study.
• Subject undergone multiple injections in tissue, using hardening agents or with history of acutely prolapsed thrombosed piles associated anal fistulas (abnormal connection between anal canal & skin), anal fissures (anal ulcer), abscess (pus under the skin surrounding the anus) or rectal prolapse.

Study & Design

• Study Type: PMS
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
- Post Operative Pain	At baseline, Post-procedure,15 days (±7 days), 3 months (±28 days) and 6 months (±28 days)
- Number of AE/SAE related to study device during 6 month of study period.	At baseline, Post-procedure,15 days (±7 days), 3 months (±28 days) and 6 months (±28 days)
- Immediate postoperative complications and short term outcomes related to study device.	At baseline, Post-procedure,15 days (±7 days), 3 months (±28 days) and 6 months (±28 days)

Secondary Outcome Measures

Name	Time	Method
1. Incidence of Stapler Malfunction or Misfires	2. Operation Time

Trial Locations

Locations (9)

Akshar Surgical Hospital and Laparoscopy Center; 🇮🇳 Surat, GUJARAT, India

Arora Surgical Hospital; 🇮🇳 Surat, GUJARAT, India

Ashirwad Surgical Hospital; 🇮🇳 Ahmadabad, GUJARAT, India

Dr Shailesh Shah Surgical Hospital and Endoscopic Clinic; 🇮🇳 Ahmadabad, GUJARAT, India

Gujarat Surgical Hospital; 🇮🇳 Vadodara, GUJARAT, India

Maitri Hospital (Surgical and Physiotherapy Hospital); 🇮🇳 Vadodara, GUJARAT, India

Parth Surgical Hospital; 🇮🇳 Ahmadabad, GUJARAT, India

Savani Surgical Hospital; 🇮🇳 Surat, GUJARAT, India

Zen Hospital; 🇮🇳 Mumbai, MAHARASHTRA, India

Akshar Surgical Hospital and Laparoscopy Center

🇮🇳Surat, GUJARAT, India

Dr Pankaj D Sakhiya

Principal investigator

9879611340

drpsakhiya78@yahoo.com