HemorrhoidNCT01169311
Safety and Performance of the Covidien EEA Hemorrhoid and Prolapse Stapling Set in a Hemorrhoidopexy Procedure
A study testing Hemorrhoidopexy in people with Hemorrhoid, run by Medtronic - MITG at 1 site in United States.
Trial summary
Trial Objectives The primary objectives of this clinical trial are to estimate the Covidien EEA™ Hemorrhoid and Prolapse Stapling Set: overall performance defined by the successful creation of a normal staple line safety as measured by the 30 day incidence of adverse events. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hemorrhoid
- What is being tested?
- Hemorrhoidopexy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2010to Jul 2011
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Able to understand and sign Informed Consent Form
- The participant must be 18-80 years of age.
- The participant has (symptomatic) Grade 2-4 Hemorrhoids and is eligible for stapled hemorrhoidopexy.
Who cannot join
- The procedure is needed as revision hemorrhoid surgery.
- The participant is pregnant.
- 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 history of drug or alcohol abuse.
- The participant has a history of venous thrombosis or pulmonary embolism.
Show all 10Show fewer
- The participant has a history of coagulopathy.
- The participant is taking aspirin, anti-coagulation and/or anti platelet therapies (e.g.: Warfarin, Levonox) within the last 7 days prior to the planned surgery date
- The participant has a history of fecal incontinence.
- 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
Weill Cornell Medical Center
New York, New York, 10065
About this study
Official title: A Prospective, Multi-Center Investigation Of The Safety And Performance Of The Covidien EEA™ Hemorrhoid And Prolapse Stapling Set With DST Series™ Technology Im A Hemorrhoidopexy Procedure
Trial Objectives
The primary objectives of this clinical trial are to estimate the Covidien EEA™ Hemorrhoid and Prolapse Stapling Set:
overall performance defined by the successful creation of a normal staple line safety as measured by the 30 day incidence of adverse events.
- Conditions
- Hemorrhoid
- Being tested
- Hemorrhoidopexy
- Keywords
- Hemorrhoids, Hemorrhoid, grade II, III, IV
- Medical subject headings
- Hemorrhoids, Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HemorrhoidopexyDevice
Also called Covidien EEA Hemorrhoid and Prolapse Stapling set
| Study group | Role | What they receive |
|---|---|---|
| HEEA Stapler | Experimental | hemorrhoidopexy using Covidien EEA Hemorrhoid and Prolapse Stapling Set Receives: Device: Hemorrhoidopexy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Uneventful Creation of a Functional Staple Line at First Firing of Device
Successful creation of staple line at first firing of device during hemorrhoidopexy
Measured: about 20 minutes for procedure
Secondary outcomes (8)
OR Time
Duration of procedure
Measured: Day 0 - Time of stop minus time of start
Intra-Operative Bleeding Requiring Intervention
Incidence of intervention for intra-operative staple-line bleeding
Measured: Day 0 - time of surgery
Length of Stay
length of time between time of admission and time of discharge
Measured: Day 0, time of discharge minus time of admission
Time to Return to Normal Activity
Measured: 30 days post op
Incidence of Stapler Malfunction or Misfires
Measured: about 20 minutes for procedure
Post Operative Pain
Post operative pain measured by 11 point visual analog scale, measured as change from baseline The scale range is 0-10, where 0 = no pain and 10 = worst possible pain
Measured: baseline, 30 days post op
Quality of Life, Physical Component
Physical component score SF36 scale measured as change from baseline the scoring ranges from 0 to 100 with 0 = unable to do anything while 100 = capable of physical activity without limitation
Measured: baseline, 30 days post op
Quality of Life, Mental Component
quality of life, SF36 measure as change from baseline the scoring ranges from 0 to 100 with 0 = complete mental activity limitation; while 100 = capable of mental activity without limitation
Measured: Baseline, 30 days post op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2010 (estimated)
- Study startJul 2010
- Primary completionMar 2011
- Study completionJul 2011
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 HemorrhoidStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic - MITG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sang Lee, M.D., Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01169311
- Sponsor's protocol ID
- COVHEPH0021
- Status last verified
- Sep 2014
- First submitted
- 22 Jul 2010
- Last updated
- 6 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 6 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multi-Center Investigation Of The Safety And Performance Of The Covidien EEA™ Hemorrhoid And Prolapse Stapling Set With DST Series™ Technology Im A Hemorrhoidopexy Procedure
- ClinicalTrials.gov ID
- NCT01169311
- Acronym / sponsor ID
- COVHEPH0021
- Conditions
- Hemorrhoid
- Keywords
- Hemorrhoids, Hemorrhoid, grade II, III, IV
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Medtronic - MITGIndustry (pharma, biotech, devices)
- Study start
- Jul 2010
- Primary completion
- Mar 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 26 Jul 2010 (estimated)
- Results
- Posted 6 Oct 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Trial Objectives
The primary objectives of this clinical trial are to estimate the Covidien EEA™ Hemorrhoid and Prolapse Stapling Set:
overall performance defined by the successful creation of a normal staple line safety as measured by the 30 day incidence of adverse events.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HEEA Stapler | Experimental | Device: Hemorrhoidopexyhemorrhoidopexy using Covidien EEA Hemorrhoid and Prolapse Stapling Set |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Able to understand and sign Informed Consent Form
- The participant must be 18-80 years of age.
- The participant has (symptomatic) Grade 2-4 Hemorrhoids and is eligible for stapled hemorrhoidopexy.
Key exclusion criteria (10 listed)
- The procedure is needed as revision hemorrhoid surgery.
- The participant is pregnant.
- 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 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 |
|---|---|---|
| HemorrhoidopexyAlso: Covidien EEA Hemorrhoid and Prolapse Stapling set | Device | HEEA Stapler |
Primary outcome
Uneventful Creation of a Functional Staple Line at First Firing of Device
Time frame: about 20 minutes for procedure
Successful creation of staple line at first firing of device during hemorrhoidopexy
8 secondary outcomes
OR Time
Time frame: Day 0 - Time of stop minus time of start
Intra-Operative Bleeding Requiring Intervention
Time frame: Day 0 - time of surgery
Length of Stay
Time frame: Day 0, time of discharge minus time of admission
Time to Return to Normal Activity
Time frame: 30 days post op
Incidence of Stapler Malfunction or Misfires
Time frame: about 20 minutes for procedure
Post Operative Pain
Time frame: baseline, 30 days post op
Quality of Life, Physical Component
Time frame: baseline, 30 days post op
Quality of Life, Mental Component
Time frame: Baseline, 30 days post op
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Sang Lee, M.D. principal investigator
Weill Medical College of Cornell University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hemorrhoidopexy in people with Hemorrhoid, 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 10 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 6 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 6 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?
Uneventful Creation of a Functional Staple Line at First Firing of Device (time frame: about 20 minutes for procedure). 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 6 Oct 2014.