| CTRI Number |
CTRI/2017/05/008476 [Registered on: 03/05/2017] Trial Registered Prospectively |
| Last Modified On: |
16/09/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Medical Device |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
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. |
|
Scientific Title of Study
|
A prospective, open-label, single-arm, multicenter, post marketing surveillance study to evaluate safety and performance of MIRUSâ„¢
Disposable Hemorrhoids Stapler in the treatment of prolapsed Hemorrhoids.
|
| Trial Acronym |
MIRUSâ„¢ Disposable Hemorrhoids Stapler |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| MES/MIRUSâ„¢-1/Version 2.0.0 dated 29-Mar-2017 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ashok Thakkar |
| Designation |
Head of Ckinical Research |
| Affiliation |
Meril Life Science Pvt Ltd |
| Address |
Meril Life Sciences Pvt Ltd,
Bilakhia House, Survey No. 135/139, Muktanand Marg, Chala, Vapi
Valsad
GUJARAT
396191
India |
| Phone |
9879443584 |
| Fax |
|
| Email |
ashok.thakkar@merillife.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ashok Thakkar |
| Designation |
Head of Ckinical Research |
| Affiliation |
Meril Life Science Pvt Ltd |
| Address |
Meril Life Sciences Pvt Ltd,
Bilakhia House, Survey No. 135/139, Muktanand Marg, Chala, Vapi
Valsad
GUJARAT
396191
India |
| Phone |
9879443584 |
| Fax |
|
| Email |
ashok.thakkar@merillife.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ashok Thakkar |
| Designation |
Head of Ckinical Research |
| Affiliation |
Meril Life Science Pvt Ltd |
| Address |
Meril Life Sciences Pvt Ltd,
Bilakhia House, Survey No. 135/139, Muktanand Marg, Chala, Vapi
Valsad
GUJARAT
396191
India |
| Phone |
9879443584 |
| Fax |
|
| Email |
ashok.thakkar@merillife.com |
|
|
Source of Monetary or Material Support
|
| Meril Endo Surgery Pvt Ltd
Bilakhia House, Survey No. 135/139, Muktanand Marg, Chala Vapi – 396191, Gujarat, India |
|
|
Primary Sponsor
|
| Name |
Meril Endo Surgery Pvt Ltd |
| Address |
Bilakhia House, Survey No. 135/139, Muktanand Marg, Chala Vapi – 396191, Gujarat, India |
| Type of Sponsor |
Other [Medical Device] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Meril Life Science Pvt Ltd |
Bilakhia House, Survey No. 135/139, Muktanand Marg, Chala Vapi – 396191, Gujarat, India. |
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 9 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Pankaj D Sakhiya |
Akshar Surgical Hospital and Laparoscopy Center |
OPD, Akshar Surgical Hospital and Laparoscopy Center, Sayona Complex, 1st Floor, Above Dairy Don Ice-cream, Hirabaug, Varachha, Surat 395006, Gujarat, India
Surat
GUJARAT |
9879611340
drpsakhiya78@yahoo.com |
| Dr Naresh Arora |
Arora Surgical Hospital |
OPD, Arora Surgical Hospital, 201, Takshashila Apartment Majura Gate, Ring Road, Surat City, Surat 950001, Gujarat, India
Surat
GUJARAT |
9687243443
drnaresharora@yahoo.co.in |
| Dr Mukesh Patel |
Ashirwad Surgical Hospital |
OPD, Wonder Point, rabari Colony and C T M Croos road, near bhavri tower, Highway Amraiwadi, Ahmedabad- 380022, Gujarat, India
Ahmadabad
GUJARAT |
7203955311
mukesh_dr@yahoo.com |
| Dr Shailesh Shah |
Dr Shailesh Shah Surgical Hospital and Endoscopic Clinic |
OPD, FF3, Vijay Tower, Opp Abad Dairy, Kankaria, Ahmedabad- 380022, Gujarat, India
Ahmadabad
GUJARAT |
9824044443
srsnss@hotmail.com |
| Dr Chandrashekher Chaturvedi |
Gujarat Surgical Hospital |
OPD, Gujarat Surgical Hospital, Chankyapuri GIPCL Circle Road, Sama Road, Vadodara 390002, Gujarat, India
Vadodara
GUJARAT |
9723788818
cscdrms5@gmail.com |
| Dr Mukesh Tailor |
Maitri Hospital (Surgical and Physiotherapy Hospital) |
OPD, Maitri Hospital
(Surgical and Physiotherapy Hospital), Labh Complex, Jetalpur Road, Anand Nagar, Near New India Mill, Vadodara 390020, Gujarat, India
Vadodara
GUJARAT |
9099011265
drmmtailor@yahoo.com |
| Dr Bhavin C Patel |
Parth Surgical Hospital |
Parth Surgical Hospital,
Out patient department, Shashi Shopping Centre,
2nd Floor, Nr Swaminarayan Avenue, Anjali Cross road, Vasan, Ahmedabad-380022, Gujarat, India
Ahmadabad
GUJARAT |
9824028514
dr_bhavin_patel@yahoo.co.in |
| Dr Amulakh Savani |
Savani Surgical Hospital |
OPD, Savani Surgical Hospital, F-10, Sarathi Complex, Hirabaug, Varachha Road, Surat 395006, Gujarat, India
Surat
GUJARAT |
9377759944
savani.amulakh@yahoo.com |
| Dr Roy Patankar |
Zen Hospital |
OPD, Zen Hospital, Plot No 425, Road Number 10, Chembur Gaothan, Near Sandu Garden, Jai Ambe Nagar, Chembur East, Mumbai 400071, Maharashtra, India
Mumbai
MAHARASHTRA |
02225223939
roypatankar@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 9 |
| Name of Committee |
Approval Status |
| Sangini Hospital Ethics Committee |
Approved |
| Sangini Hospital Ethics Committee |
Approved |
| Sangini Hospital Ethics Committee |
Approved |
| Sangini Hospital Ethics Committee |
Approved |
| Sangini Hospital Ethics Committee |
Approved |
| Sangini Hospital Ethics Committee |
Approved |
| Sangini Hospital Ethics Committee |
Approved |
| Sangini Hospital Ethics Committiee |
Approved |
| Sangini Hospital Ethics Committiee |
Approved |
|
Regulatory Clearance Status from DCGI
Modification(s)
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
MIRUSâ„¢ Disposable Hemorrhoids Stapler |
MIRUSâ„¢ Disposable Hemorrhoids Stapler in the treatment of prolapsed hemorrhoids. |
| Comparator Agent |
NA |
NA |
|
Inclusion Criteria
Modification(s)
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
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.
2. 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.
OR
3. Subjects with grade III (prolapsing internal hemorrhoids requiring manual reduction) and/or grade IV (irreducible prolapse) are suitable candidate with stapled hemorrhoidopexy.
4. 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.
5. Subject must follow the post-operative follow-up visits for 6 months. |
|
| ExclusionCriteria |
| Details |
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.
2. 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.
3. Subject’s tissue has undergone multiple injections of hardening agent at hemorrhoids.
4. The subject has a history of fecal incontinence.
5. 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.
6. The subject has a history of venous thrombosis or pulmonary embolism.
7. The subject has a history of coagulopathy.
8. 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.
9. 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.
10. 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. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
- Immediate postoperative complications and short term outcomes related to study device.
- Number of AE/SAE related to study device during 6 month of study period.
- Post Operative Pain |
At baseline, Post-procedure,15 days (±7 days), 3 months (±28 days) and 6 months (±28 days) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Incidence of Stapler Malfunction or Misfires
2. Operation Time
3. Length of Hospital Stay
4. Reapparition of the hemorroidal symptoms and/or
Reoperations
5. Standardized Stapled Hemmorrhoidectomy Quality Of
Life (QOL)
6. Overall Quality of Life |
At baseline, About 20 minutes for procedure, Day 0, time of discharge minus time of admission , 15 days (±7 days), 3 months (±28 days) and 6 months (±28 days) |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
08/05/2017 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="28" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
Not Available |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This is a prospective, open-label, single-arm, multi-center, post marketing surveillance study to evaluate safety and performance of MIRUS™ 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). |