GossyphibomaNCT02538887
Use of a Supplemental Radiofrequency Detection System Subsequent to Manual Counting of Vaginal Textiles Following Vaginal Birth
An observational study of Gossyphiboma, run by The University of Texas Health Science Center, Houston.
Trial summary
The purpose of this study is to evaluate the FDA-approved Radio Frequency Surgical Detection System (RFDS) as a non-radiological means to ease the process of detecting retained sponges and reconciling sponge counts in the labor and delivery room (following vaginal birth). Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Gossyphiboma
- What is being tested?
- Radio Frequency Surgical Detection
- Type of treatment
- Medical device
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Nov 2015to May 2016
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: All subjects will be inpatients at UTHealth/Memorial Hermann Hospital (and affiliates) who are awaiting vaginal birth. Subjects will be identified upon admittance to Labor and Delivery triage.
Who may be able to join
- Adults only, 18 years or older
- Admitted as inpatients to labor and delivery; patients must be in anticipation of vaginal delivery
Who cannot join
- Urgent or emergent admissions under the influence of preoperative medication, drugs or alcohol.
- Age less than 18 years,
- The patient does not understand English well enough to adequately understand the study.
- Hesitancy of the patient to participate or family reluctance based on the study doctor's opinion.
About this study
Official title: Use of a Supplemental Radiofrequency Detection System Subsequent to Manual Counting of Vaginal Textiles Following Vaginal Birth: A Prospective Effectiveness and Efficiency Study For Sponge Tracking
The purpose of this study is to evaluate the FDA-approved Radio Frequency Surgical Detection System (RFDS) as a non-radiological means to ease the process of detecting retained sponges and reconciling sponge counts in the labor and delivery room (following vaginal birth).
Read the detailed description
This study proposes to evaluate the FDA-approved Radio Frequency Surgical Detection System (RFDS) as a non-radiological means to ease the process of detecting retained sponges and reconciling sponge counts in the labor and delivery room (following vaginal birth). It would not replace any of the current standard-of-care safety mechanisms already in place at the study site to prevent retained sponges. All safeguards remain enforced: counting, visual inspection, and x-rays if indicated by standard protocol. The system being studied involves the surgeon scanning the subject's vaginal area using a spherical device placed 1cm above the symphysis pubis. This static scan will serve to detect any retained cotton textiles within the vaginal cavity after birth. This Verisphere, a reusable device, is encased in a sterile sheath during use. It does not come into direct contact with the subject's vagina, but hovers above the pelvic/vaginal region. If any radio-frequency tagged sponges remain inside the subject, a signal alerts the surgical team to remove them. The visible console displays a confirmation code once the scan is complete. This confirmation code is kept as part of the medical record once absence of retained textiles is confirmed. Once the provider is assured there is no retained item, the same device may be used to scan trash receptacles to locate a missing textile if the pre- and post-delivery sponge/gauze count remains incongruent. This alleviates the need for the assistant personnel to manually "dig" through soiled materials for sponge localization.
- Conditions
- Gossyphiboma
- Being tested
- Radio Frequency Surgical Detection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radio Frequency Surgical DetectionDevice
| Study group | Role | What they receive |
|---|---|---|
| Radio Frequency Surgical Detection | Not described Receives: Device: Radio Frequency Surgical Detection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients for whom surgical sponge counts can't be reconciled
Measured: at the time of radio frequency surgical detection
Number of patients for whom an X-ray was required
Measured: at the time of radio frequency surgical detection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2015 (estimated)
- Study startNov 2015 (estimated)
- Primary completionMay 2016 (estimated)
- Study completionMay 2016 (estimated)
Why it stopped: Sponsor dissolved before study started
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GossyphibomaStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Teresa Byrd, MD, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02538887
- Sponsor's protocol ID
- HSC-MS-15-0535
- Status last verified
- Nov 2020
- First submitted
- 31 Aug 2015
- Last updated
- 5 Nov 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of a Supplemental Radiofrequency Detection System Subsequent to Manual Counting of Vaginal Textiles Following Vaginal Birth: A Prospective Effectiveness and Efficiency Study For Sponge Tracking
- ClinicalTrials.gov ID
- NCT02538887
- Acronym / sponsor ID
- HSC-MS-15-0535
- Conditions
- Gossyphiboma
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Sponsor dissolved before study started
- Enrolment
- 0 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- Nov 2015 (estimated)
- Primary completion
- May 2016 (estimated)
- Study completion
- May 2016 (estimated)
- First posted
- 2 Sep 2015 (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.
The purpose of this study is to evaluate the FDA-approved Radio Frequency Surgical Detection System (RFDS) as a non-radiological means to ease the process of detecting retained sponges and reconciling sponge counts in the labor and delivery room (following vaginal birth).
Detailed description
This study proposes to evaluate the FDA-approved Radio Frequency Surgical Detection System (RFDS) as a non-radiological means to ease the process of detecting retained sponges and reconciling sponge counts in the labor and delivery room (following vaginal birth). It would not replace any of the current standard-of-care safety mechanisms already in place at the study site to prevent retained sponges. All safeguards remain enforced: counting, visual inspection, and x-rays if indicated by standard protocol. The system being studied involves the surgeon scanning the subject's vaginal area using a spherical device placed 1cm above the symphysis pubis. This static scan will serve to detect any retained cotton textiles within the vaginal cavity after birth. This Verisphere, a reusable device, is encased in a sterile sheath during use. It does not come into direct contact with the subject's vagina, but hovers above the pelvic/vaginal region. If any radio-frequency tagged sponges remain inside the subject, a signal alerts the surgical team to remove them. The visible console displays a confirmation code once the scan is complete. This confirmation code is kept as part of the medical record once absence of retained textiles is confirmed. Once the provider is assured there is no retained item, the same device may be used to scan trash receptacles to locate a missing textile if the pre- and post-delivery sponge/gauze count remains incongruent. This alleviates the need for the assistant personnel to manually "dig" through soiled materials for sponge localization.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Radio Frequency Surgical Detection | – | Device: Radio Frequency Surgical Detection |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All subjects will be inpatients at UTHealth/Memorial Hermann Hospital (and affiliates) who are awaiting vaginal birth. Subjects will be identified upon admittance to Labor and Delivery triage.
Key inclusion criteria (2 listed)
- Adults only, 18 years or older
- Admitted as inpatients to labor and delivery; patients must be in anticipation of vaginal delivery
Key exclusion criteria (4 listed)
- Urgent or emergent admissions under the influence of preoperative medication, drugs or alcohol.
- Age less than 18 years,
- The patient does not understand English well enough to adequately understand the study.
- Hesitancy of the patient to participate or family reluctance based on the study doctor's opinion.
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 |
|---|---|---|
| Radio Frequency Surgical Detection | Device | Radio Frequency Surgical Detection |
Primary outcome
Number of patients for whom surgical sponge counts can't be reconciled
Time frame: at the time of radio frequency surgical detection
Number of patients for whom an X-ray was required
Time frame: at the time of radio frequency surgical detection
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2020.
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.
Teresa Byrd, MD principal investigator
The University of Texas Health Science Center, Houston
Questions about this trial
What is this clinical trial studying?
An observational study of Gossyphiboma, run by The University of Texas Health Science Center, Houston.
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 2 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: withdrawn, as of the sponsor's last update on 5 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Number of patients for whom surgical sponge counts can't be reconciled (time frame: at the time of radio frequency surgical detection). The study lists 2 primary outcomes in all. 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 5 Nov 2020.