Comparing Two Clamps for Mobilization of the Cervix During Common Gynecologic Office ProceduresOB39NCT01769131
A Comparison of Two Instruments for Stabilization of the Cervix During Office Procedures
An observational study of Comparing Two Clamps for Mobilization of the Cervix During Common Gynecologic Office Procedures, run by Carilion Clinic at 1 site in United States.
Trial summary
An Allis clamp causes less pain and bleeding than a single tooth tenaculum when used for mobilization of the cervix during common gynecologic office procedures. The primary object is to determine the presence of a difference in pain perception between the two instruments. Read more about this study
- Who is it for?
- Ages 18 to 89 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Comparing Two Clamps for Mobilization of the Cervix During Common Gynecologic Office Procedures
- How many people
- 81 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2012to Dec 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
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 89 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Females between the ages of 18 and 89 years undergoing an IUD placement
Who may be able to join
- Female
- Between 18 and 89 years of age
- Undergoing an IUD placement
Who cannot join
- IUD placement within the last 6 months
- Active cervical or pelvic infection
- pregnant
- Patient taking coagulation medications
Trial locations and contacts
1 site in 1 country.
About this study
An Allis clamp causes less pain and bleeding than a single tooth tenaculum when used for mobilization of the cervix during common gynecologic office procedures.
The primary object is to determine the presence of a difference in pain perception between the two instruments.
The secondary objective is to evaluate the differences in the frequency of bleeding, that requires treatment, after removal of the instrument and the need to use an alternative instruments.
- Conditions
- Comparing Two Clamps for Mobilization of the Cervix During Common Gynecologic Office Procedures
- Keywords
- cervix, Allis, Tenaculum, gynecology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Allis | Not described | |
| Tenaculum | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
A comparison of two instruments for stabilization of the cervix during office procedures
Primary - to determine the presence of a difference in pain perception between the two instruments.
Measured: 1 year
Secondary outcomes (1)
A comparison of two instruments for stabilization of the cervix during office procedures
Secondary - To evaluate the differences in the frequency of bleeding, that required treatment, after removal of the instruct and the need to use an alternative instrument.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2013 (estimated)
- Study startSep 2012
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Comparing Two Clamps for Mobilization of the Cervix During Common Gynecologic Office ProceduresStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Carilion Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Isaiah Johnson, Carilion Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01769131
- Sponsor's protocol ID
- OB39
- Acronym
- OB39
- Status last verified
- Aug 2015
- First submitted
- 14 Jan 2013
- Last updated
- 4 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Two Instruments for Stabilization of the Cervix During Office Procedures
- ClinicalTrials.gov ID
- NCT01769131
- Acronym / sponsor ID
- OB39 / OB39
- Conditions
- Comparing Two Clamps for Mobilization of the Cervix During Common Gynecologic Office Procedures
- Keywords
- cervix, Allis, Tenaculum, gynecology
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Carilion ClinicUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 16 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
An Allis clamp causes less pain and bleeding than a single tooth tenaculum when used for mobilization of the cervix during common gynecologic office procedures.
The primary object is to determine the presence of a difference in pain perception between the two instruments.
The secondary objective is to evaluate the differences in the frequency of bleeding, that requires treatment, after removal of the instrument and the need to use an alternative instruments.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Allis | – | – |
| Tenaculum | – | – |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Females between the ages of 18 and 89 years undergoing an IUD placement
Key inclusion criteria (3 listed)
- Female
- Between 18 and 89 years of age
- Undergoing an IUD placement
Key exclusion criteria (4 listed)
- IUD placement within the last 6 months
- Active cervical or pelvic infection
- pregnant
- Patient taking coagulation medications
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
A comparison of two instruments for stabilization of the cervix during office procedures
Time frame: 1 year
Primary - to determine the presence of a difference in pain perception between the two instruments.
1 secondary outcome
A comparison of two instruments for stabilization of the cervix during office procedures
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2015.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Comparing Two Clamps for Mobilization of the Cervix During Common Gynecologic Office Procedures, run by Carilion Clinic 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 4 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 4 Aug 2015. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
A comparison of two instruments for stabilization of the cervix during office procedures (time frame: 1 year). 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 4 Aug 2015.