HemorrhoidsHEMOSTASISNCT01306877
Comparison Study of Surgical Staplers for the Treatment of Hemorrhoids
A study testing EEA Hemorrhoid and Prolapse Stapling Set and Endosurgery Proximate PPH03 Stapling Set in people with Hemorrhoids, run by Medtronic - MITG at 1 site in United States.
Trial summary
The purpose of this study is to demonstrate that the Covidien EEA™ Hemorrhoid and Prolapse Stapling Set for the treatment of hemorrhoids is non-inferior to the competitor device based on the primary endpoint. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Hemorrhoids
- What is being tested?
- EEA Hemorrhoid and Prolapse Stapling Set and Endosurgery Proximate PPH03 Stapling Set
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 149 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2011to Jan 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The subject is able to understand and sign Informed Consent Form
- The subject is between 18-85 years of age.
- The subject has (symptomatic) Grade 2-3 Hemorrhoids and is eligible for stapled hemorrhoidopexy
Who cannot join
- The procedure is needed as revision hemorrhoid surgery.
- Any female patient, who is pregnant, suspected pregnant, or nursing.
- The participant has an active or a history of infection requiring antibiotics at the intended operative site within thirty (30) days prior to the planned surgery date.
- The participant is unable or unwilling to comply with the study requirements, follow-up schedule.
- The participant has a 1 year history of drug or alcohol abuse.
- The participant has a history of venous thrombosis or pulmonary embolism.
Show all 11Show fewer
- The participant has a history of coagulopathy.
- The participant 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 participant has a history of fecal incontinence
- The participant has had injection therapy, infrared laser treatment or rubber band ligation for treatment of hemorrhoids within 1 month of screening
- The participant has co-morbidities which, in the opinion of the investigator, will not be appropriate for the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
USF Tampa General Hospital Dept of Surgery
Tampa, Florida, 33606
About this study
Official title: Prospective Single Blinded Randomized Controlled Trial Comparing The Covidien EEA™ Hemorrhoid and Prolapse Stapling Set With DST Series™ Technology Vs. Ethicon PPH03 In A Hemorrhoidopexy Procedure (HEMOSTASIS)
The purpose of this study is to demonstrate that the Covidien EEA™ Hemorrhoid and Prolapse Stapling Set for the treatment of hemorrhoids is non-inferior to the competitor device based on the primary endpoint.
- Conditions
- Hemorrhoids
- Being tested
- EEA Hemorrhoid and Prolapse Stapling Set, Endosurgery Proximate PPH03 Stapling Set
- Keywords
- hemorrhoid, hemorrhoid stapler
- Medical subject headings
- Hemorrhoids
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EEA Hemorrhoid and Prolapse Stapling SetDevice
Surgical device
Endosurgery Proximate PPH03 Stapling SetDevice
Surgical device
| Study group | Role | What they receive |
|---|---|---|
| EEA Hemorrhoid and Prolapse Stapling Set | Experimental | Not described Receives: Device: EEA Hemorrhoid and Prolapse Stapling Set |
| Endosurgery Proximate PPH03 Stapling Set | Active comparator | Not described Receives: Device: Endosurgery Proximate PPH03 Stapling Set |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraoperative Bleeding
Number of subjects who require intervention to stop intraoperative bleeding The analysis is based on the per protocol analysis set. Subjects who were misrandomized for excluded from this analysis therefore, the population here will differ from the participant flow.
Measured: Day 0 - time of surgery
Secondary outcomes (6)
Post Operative Pain - (PI-NIRS)
Post-operative pain as change from baseline pain score as measured by an 11-point Pain Intensity Numeric Rating Scale (PI-NRS). The range of the scale is 0-10 with 0 representing no pain and 10 representing the worst possible pain.
The data represented is the change in baseline score at the different timepoints.
Measured: Day 0 minus 60 (baseline), Day 0 (discharge), Day 0 plus 7, Day 0 plus 30, Day 0 plus 90, Day 0 plus 180
Post-Operative Pain (Analgesic Intake)
post operative pain measured in pos-surgical consumption of strong opioids by the number of participants in the study. Participants are included if they consumed analgesics or strong opiod at anytime during the study.
Measured: Day 0, 1 week, 2 week, 1 month, 3 month, 6 month
Overall Quality of Life - General Health Score
Quality of life was measured by SF-12 questionnaire in change from baseline; the socring range is 0 - 100 with 0 = poor overall health and 100 = excellent overall health
Measured: Day 0 minus 60, 1 week, 1 month, 3 months, 6 months
Location of the Staple Line
Distance of staple line to dentate line as measure by surgical ruler
Measured: Day 0
Length of Stay
Length of hospital stay is defined as time of anoscope insertion until discharge
Measured: Day 0 time of discharge minus time of admission
Operative Room (OR) Time
Time of insertion of anoscope to time of anoscope removal after stapleline evaluation
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2011 (estimated)
- Study startJan 2011
- Primary completionAug 2012
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HemorrhoidsStudies of the same condition, open and under way.
- More trials run by Medtronic - MITGThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 149 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic - MITG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jorge Marcet, MD, Principal investigator, University of South Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01306877
- Sponsor's protocol ID
- COVHEPH0109
- Acronym
- HEMOSTASIS
- Status last verified
- Oct 2014
- First submitted
- 28 Jan 2011
- Last updated
- 29 Oct 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Single Blinded Randomized Controlled Trial Comparing The Covidien EEA™ Hemorrhoid and Prolapse Stapling Set With DST Series™ Technology Vs. Ethicon PPH03 In A Hemorrhoidopexy Procedure (HEMOSTASIS)
- ClinicalTrials.gov ID
- NCT01306877
- Acronym / sponsor ID
- HEMOSTASIS / COVHEPH0109
- Conditions
- Hemorrhoids
- Keywords
- hemorrhoid, hemorrhoid stapler
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 149 participants (actual)
- Lead sponsor
- Medtronic - MITGIndustry (pharma, biotech, devices)
- Study start
- Jan 2011
- Primary completion
- Aug 2012 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 2 Mar 2011 (estimated)
- Results
- Posted 29 Oct 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to demonstrate that the Covidien EEA™ Hemorrhoid and Prolapse Stapling Set for the treatment of hemorrhoids is non-inferior to the competitor device based on the primary endpoint.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EEA Hemorrhoid and Prolapse Stapling Set | Experimental | Device: EEA Hemorrhoid and Prolapse Stapling Set |
| Endosurgery Proximate PPH03 Stapling Set | Active comparator | Device: Endosurgery Proximate PPH03 Stapling Set |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- The subject is able to understand and sign Informed Consent Form
- The subject is between 18-85 years of age.
- The subject has (symptomatic) Grade 2-3 Hemorrhoids and is eligible for stapled hemorrhoidopexy
Key exclusion criteria (11 listed)
- The procedure is needed as revision hemorrhoid surgery.
- Any female patient, who is pregnant, suspected pregnant, or nursing.
- The participant has an active or a history of infection requiring antibiotics at the intended operative site within thirty (30) days prior to the planned surgery date.
- The participant is unable or unwilling to comply with the study requirements, follow-up schedule.
- The participant has a 1 year history of drug or alcohol abuse.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EEA Hemorrhoid and Prolapse Stapling SetSurgical device | Device | EEA Hemorrhoid and Prolapse Stapling Set |
| Endosurgery Proximate PPH03 Stapling SetSurgical device | Device | Endosurgery Proximate PPH03 Stapling Set |
Primary outcome
Intraoperative Bleeding
Time frame: Day 0 - time of surgery
Number of subjects who require intervention to stop intraoperative bleeding The analysis is based on the per protocol analysis set. Subjects who were misrandomized for excluded from this analysis therefore, the population here will differ from the participant flow.
6 secondary outcomes
Post Operative Pain - (PI-NIRS)
Time frame: Day 0 minus 60 (baseline), Day 0 (discharge), Day 0 plus 7, Day 0 plus 30, Day 0 plus 90, Day 0 plus 180
Post-Operative Pain (Analgesic Intake)
Time frame: Day 0, 1 week, 2 week, 1 month, 3 month, 6 month
Overall Quality of Life - General Health Score
Time frame: Day 0 minus 60, 1 week, 1 month, 3 months, 6 months
Location of the Staple Line
Time frame: Day 0
Length of Stay
Time frame: Day 0 time of discharge minus time of admission
Operative Room (OR) Time
Time frame: Day 0
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Hemorrhoids
Not yet recruiting
Auricular Indwelling Needles Added to Diosmin/Hesperidin for Grade I-II Internal Hemorrhoids With Heat-Toxin Syndrome
Internal Haemorrhoids
Enrolling by invitation
Ultrasound-Guided Versus Landmark-Guided Pudendal Block for Post-Hemorrhoidectomy Pain
Hemorrhoids, Postoperative Pain
Not yet recruitingObservational study
Bleeding Reduction in Grade II-III Haemorrhoids Through Embolization Treatment
Hemorrhoid, Hemorrhoid Bleeding
Recruiting
Ligasure Versus Conventional Diathermy in Hemorrhoidectomy
Hemorrhoids
Enrolling by invitationObservational study
Case-Specific Health Care Professional Clinical Survey for Concerto Versa™ Detachable Coils
Arteriovenous Malformation, Gastrointestinal Bleed
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jorge Marcet, MD principal investigator
University of South Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EEA Hemorrhoid and Prolapse Stapling Set and Endosurgery Proximate PPH03 Stapling Set in people with Hemorrhoids, run by Medtronic - MITG at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Oct 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraoperative Bleeding (time frame: Day 0 - time of surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2014.