Validation of Chloe SED, a reusable, low-cost syringe extension device for the provision of paracervical analgesia during gynecologic procedures

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

PACTR

Registry ID

PACTR202111738348757

Enrollment

210

Registered

2021-11-10

Start date

2021-12-01

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Incomplete Miscarriage

Interventions

SPINAL NEEDLE

CHLOE SED

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: ? Women’s health providers providing MVA services. ? Female patients receiving MVA at the two study sites. These women will be determined clinically eligible for MVA treatment by a icensed Kenyan Medical Officer or Clinical Officer who has evaluated them. ? Ability to consent and understand that participation in the study involves potential use of a new device during the planned MVA. ? Age 18 years or greater.

Exclusion criteria

Exclusion criteria: • Males will be excluded from the patient population as men do not receive MVA services. Male MVA providers will not be excluded from the provider population. • All persons under the age of 18 will be excluded. • Any member of the research team (including PI and Co-Is) who is also a women’s health provider will be excluded so as to avoid bias. • There is no exclusion based on race, tribe, religion or sexual orientation in the study for any patients or providers who meet inclusion criteria. There are no exclusions for patients based on language. • Contraindications to lidocaine or patients with increased risks to MVA procedure (as determined by PPB in the initial pilot study) which include the following: ? Known or suspected hypersensitivity to lidocaine ? Skin infection adjacent to proposed site of injection (for MVA this would include uterine and cervical infection) ? Concomitant anticoagulant therapy or an abnormal bleeding tendency ? Severe anemia or heart disease. Severe anemia will be defined as per the WHO, as anemia associated with symptoms of fatigue, weakness, dizziness, and drowsiness or known haemoglobin concentration less than 7.0 g/dL

Design outcomes

Primary

Measure	Time frame
Pain scores on the Numerical Rating Scale - NRS scale	—

Secondary

Measure	Time frame
Patient experiences and preferences during MVA	—

Countries

Kenya

Contacts

Public ContactRobert Bailey

Proffessor

rcbailey@uic.edu+13129966620

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Aug 9, 2026