The Carevix Device: Assessing Pain and Effectiveness of a Suction-based Cervical Stabilizer for IUD Insertions in the Clinic Setting: a Randomized, Controlled Trial (CARE)
Phase: NA
Conditions: IUD, Abnormal Uterine Bleeding, Pain, Cervical
Sponsor: Indiana University

 
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The Carevix™ Device: Assessing pain and effectiveness of a suction-
based cervical stabilizer for IUD insertions in the clinic setting: a 
randomized, controlled (CARE) trial 
 
 
Principal Investigator:  
Alissa Conklin, MD, FACOG 
Assistant Professor 
Department of Obstetrics & Gynecology 
Indiana University 
550 N University Blvd 
Suite 2441 
Indianapolis, IN 46202 
 
 
 
 

 
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Table of Contents: 
Study Schema 
1.0 
Background & Rationale 
2.0 
Objective(s) 
2.1 
Primary Objective 
2.2 
Secondary Objective 
2.3 
Tertiary/Exploratory/Correlative Objectives 
3.0 
Outcome Measures 
3.1 
Primary Outcome Measures 
3.2 
Secondary Outcome Measures 
3.3 
Tertiary/ Exploratory/ Correlative Outcome Measures 
4.0 
Eligibility Criteria 
4.1 
Inclusion Criteria 
4.2 
Exclusion Criteria 
4.3 
Other Criteria 
5.0 
Study Design 
6.0 
Enrollment 
7.0 
Study Procedures 
8.0 
Study Calendar 
9.0 
Reportable Events 
10.0 
Data Safety Monitoring 
11.0 
Study Withdrawal/Discontinuation 
12.0 
Statistical Considerations 
13.0 
Data Management 
14.0 
Privacy/Confidentiality Issues 
15.0 
Follow-up and Record Retention 
16.0 
References 
Appendix 
Abbreviations 
AE 
Adverse Event 
HIPAA 
Health Insurance Portability and Accountability Act  
IRB 
Institutional Review Board 
PI 
Principal Investigator 
PHI 
Personal Health Information 
RCT 
Randomized Controlled Trial 
SAE 
Serious Adverse Event 
US 
United States 
IUD 
Intrauterine Device 
EMB 
Endometrial Biopsy 
FDA 
Food and Drug Administration 
 
 

 
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1.0 Background & Rationale 
IUD insertions can be painful.  Pain at IUD insertion is experienced in a wide range, with some patients feeling 
little to no pain and others feeling excruciating pain.  Fear of IUD insertion pain and pre-procedure anxiety has 
been shown to cause a higher level of pain during the procedure.1 In August 2024, the CDC released a statement 
encouraging a person-centered plan for pain management during IUD insertions and that all patients should be 
counseled on potential pain as well as the risks, benefits and alternatives for different pain management options.2 
Of note, there is no study other than the 2023 Aspivix European trial on this device, that emphasizes pain 
specifically at cervical grasp during IUD insertions.3  Additionally, studies are beginning to assess the role cultural 
and background characteristics of patients play into the pain experience. One 2020 study showed that race was 
the only covariate that significantly predicted anticipated pain at IUD insertion and that women with anticipated 
pain scores above the median had significantly higher perceived pain during all timepoints of the IUD insertion 
procedure.4  One study in 2018 tried to assess racial differences in attitude towards IUDs and found that 
knowledge about IUDs did not differ based on race but Black women were more likely to perceive that they had 
less knowledge about IUDs compared to white women.5  Pain as a barrier to IUD uptake has been studied and the 
results are mixed.  One study in 2016 found women who initiated other contraceptives (i.e. oral birth control, 
injectables, implant, patch, etc.)  did not anticipate more pain with IUD insertion than those who initiated IUD6, 
but a more recent study in 2024 found fear of pain related to the insertion process as one of the most significant 
barriers to the use of the IUD.  This review of 14 studies in total, found that most looked only at pharmacological 
methods for pain management with IUD insertion, highlighting a need for more research on non-pharmacological 
methods to improve patient experience and reduce associated fears.7  
 
When IUD insertions are performed, often the cervix needs to be stabilized to facilitate intrauterine entry.  The 
standard approach for cervical stabilization is an invasive, sharp instrument called a tenaculum.  This leaves two 
punctures on the cervix, which can be painful and bleed, which can prolong an IUD insertion procedure.  Aspivix ™ 
has created a suction-based atraumatic cervical stabilizer for use with such intrauterine procedures.  The First-in-
Woman study (RCT with 100 patients) completed in 2 renowned University Hospitals in Switzerland showed 
positive results in both pain reduction and bleeding (pain reduced by up to 73% and bleeding occurrence reduced 
by 78%). This new device is fully FDA approved in January 2023.   
 
Attached are the company's clinical brochure showing the device, explaining how it is used, and data on 
effectiveness.  In addition, this is the RCT publication on the journal Contraception on this device, showing the 
data cited above.3 
https://www.contraceptionjournal.org/article/S0010-7824(23)00066-5/fulltext 
 

 
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In 2023, Aspivix ™ launched the AMBASSADOR PROGRAM, a 3–6-month program with free of charge devices for 
selected hospitals /clinics willing to test extensively Carevix™ in multiple transcervical procedures. 
 
During this time, the Coleman Clinic at Indiana University performed the first trial in the United States utilizing this 
device on intrauterine procedures at a single site (between 11/2023 to 5/2024) as an expansion of the 2023 
European trial.  This pilot study involved 60 total patients – 30 patients received tenaculum and 30 received 
Carevix™.  In this study, we expanded to include not only IUD insertions, but also endometrial biopsies and saline 
infusion sonograms.  We also collected some demographic data, including age, relationship status, education 
level, current work status, and pregnancy history.  We did not collect ethnicity or additional cultural identification 
that may play a role in reproductive decision making, nor did we collect any prior pregnancy prevention strategies 
the patient had used, why they no longer want to use those options and why they elected for an IUD nor any 
barriers perceived or anticipated for device removal. 
 
As stated by the recently updated recommendations by the CDC on 8/8/2024 regarding pain management for IUD 
insertions (attachment, beginning on page 13), pain and fear of pain during IUD insertions can be a barrier to this 
highly effective, long-acting form of reversible contraception.  The CDC also encourages a person-centered plan 
for IUD placement and pain management during IUD insertions, which should include non-pharmacological 
choices.  As stated in the new CDC recommendations: “barriers to IUD use include patient concerns about 
anticipated pain with placement and provider concerns about ease of placement, especially among nulliparous 
patients.”  This trial directly addresses this CDC call by seeking to expand non-pharmacological options available to 
patients to potentially decrease pain during IUD insertions by studying the new suction-based cervical stabilizer, 
which has only recently begun use in the United States.  As stated in the European trial, the Carevix™ device has 
the potential to decrease pain experienced by the patient, decrease bleeding and therefore potentially time spent 
during the procedure for both the provider and the patient, and had no difference in visibility by the provider.  
This is very timely with the new CDC recommendations and an IUD insertion-focused randomized trial to study 
this device on patients in the United States is needed. 
 
The population this study will focus on is a generally urban-based population but of a large variety of economic, 
ethnic, social and age- and education-based background.  This population is generally of reproductive age, but 
ranges between 18 and 50.  Most identify as female.  IU Health-based clinics accept all private and Medicaid-
based insurances and include patients with no insurance and this patient population will reflect that variety.  
Generally, most patients in this study will live and work within the state of Indiana, which also has a near-total 
abortion ban.  In addition, the European data found nulliparous women had much less pain with Carevix™ 
compared to tenaculum than multiparous women did.  We seek to determine if a similar finding is noted in our 

 
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population as well as other demographic data that can further align better person-centered contraceptive choices 
and counseling surrounding pain management for IUD insertion. 
 
 
2.0 Objective(s) 
2.1 
Primary Objective 
2.1.1 
Primary Objective: to assess and compare patient-reported pain during IUD insertion 
between the Carevix device and tenaculum. Our hypothesis is that patient-reported pain 
scores comparing Carevix™ to tenaculum will be lower. We will assess pain, and 
predictors for pain scores including nulliparous vs multiparous, when highest pain scores 
are reported, and expectation of pain for the procedure.  
2.2 
Secondary Objective 
Secondary Objectives: We will assess Usability (provider assessment of ease of use, number of device 
placement attempts to secure sufficient traction on uterus), efficacy (ability to insert IUD with Carevix™ 
device alone without recourse to conventional tenaculum or other instruments), provider reported 
bleeding (cervical bleeding and ecchymosis), overall provider satisfaction, patient-reported pain scores 
at device placement prior to IUD insertion procedure and after completion of IUD insertion using Visual 
Analog Scale (VAS), overall patient satisfaction, and overall provider satisfaction. We aim to expand our 
pilot trial data collection to assess cultural background, ethnicity and demographics while also assessing 
prior contraceptive choices, reasons for discontinuation of prior choices and reasons for current 
selection of IUD insertion and any anticipated barriers for removal. 
 
3.0 Outcome Measures/Endpoints 
3.1 
Primary Outcome Measures 
3.1.1 
Primary outcome measures: To assess patient-reported pain, a questionnaire 
(Attachment #2) will be done after completing the procedure.  This takes on average 1-2 
minute to complete.   
3.2 
Secondary Outcome Measures 
3.2.1 
Secondary outcome measures: To assess provider-reported ease of use and provider 
satisfaction with the device, the provider will complete a questionnaire following the 
patient’s completion of their portion of the questionnaire (Attachment #3).  This takes on 
average 1-2 minutes to complete. To assess cultural background, ethnicity and 

 
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demographics while also assessing prior contraceptive choices and reasons for current 
selection of IUD insertion, these questions will be answered in same survey as primary 
outcome measure after completing the procedure.   
 
 
4.0 Eligibility Criteria 
4.1 
Inclusion Criteria (to be assessed prior to procedure) 
• 
Age 18 years or older 
• 
Able to consent on their own 
• 
Scheduled and will undergo an IUD insertion within 90 days of consent 
• 
Planned use of cervical stabilization device for placement 
• 
Procedure being performed by a trained provider 
• 
Provider is willing to use Carevix™ for scheduled procedure 
 
4.2 
Exclusion Criteria (to be assessed by provider at time of procedure) 
• 
Vaginal bleeding of unknown origin 
• 
Cervix less than 26 mm in diameter 
• 
Nabothian cyst on anterior lip of cervix 
• 
Cervical myomas 
• 
Cervical abnormalities/shape 
• 
Pregnant 
• 
Participants who are not fluent in and/or do not fully understand, read, write, or speak 
the English language 
• 
Other inability to provide informed consent to participate 
• 
Initial attempt to place the IUD without any cervical stabilization 
 
4.3 
Other Criteria 
4.3.1 
If the patient does not require ANY cervical stabilization after consent, the subject status 
will be considered ineligible for device placement and will be excluded. These patients 
will be replaced by another eligible recruit. 
4.3.2 
This trial will be conducted with intention-to-treat analysis.  If a patient is randomized into 
the Carevix™ arm and Carevix™ is attempted but the procedure is unable to be completed 

 
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with the Carevix™ and instead a tenaculum is required, their data will be analyzed in the 
Carevix™ arm. An exploratory “as treated” analysis may be performed if >15% of patients 
get an intervention not originally randomized. 
5.0 Study Design 
Indiana University Health clinics will perform a randomized trial on Carevix™ vs tenaculum for IUD insertions.  All 
patients presenting for IUD insertion who fit inclusion criteria will be approached with this study.  Upon consent 
and review of the study information sheet (attached), they will be randomized to receive either the Carevix™ 
device or the tenaculum.  The patient will be consented for the IUD insertion as per normal clinic protocol and for 
the study as per study protocol. 
 
Randomization will occur by block randomization to ensure that equal numbers are allocated to each group.  To 
accomplish this, study staff will utilize a random number generator to assign interventions, blocked in groups of 6. 
In order to account for potentially pivotal differences, we will stratify randomization on two characteristics, 
randomizing nulliparous and parous patients separately, as well as individual clinic. All assignments then being put 
into sealed, opaque, sequentially numbered envelopes to be chosen by study staff after the participant has 
consented to the study. Once the envelope is chosen the patient and provider will be made aware of which arm 
the participant is allocated.  Due to the nature of the devices, participants and care providers are unable to be 
blinded for this study. 
 
Baseline characteristics and demographics will be collected on all participants enrolled, flow of participants 
through study using CONSORT diagram, number and reasons participants not randomized, and comparison 
between those randomized and those not randomized. All participants randomized reported according to 
Intention-to-Treat (ITT) principle. Number and reasons for switching from Carevix™ to the standard cervical 
traction device (tenaculum), or the converse, will be reported. Device efficacy and usability outcomes, and 
participant pain assessments and outcomes to be compared by randomized arm, and within Carevix™ arm 
according to actual method used.  
 
Power analysis: For our analysis, we used the Wilcoxon test instead of the t-test because we anticipate that the 
data will not be normally distributed, based on the results of our pilot study. Since the Wilcoxon test does not rely 
on the normality assumption, we used a simulation approach to estimate the power rather than the t-test power 
analysis. In the pilot trial dataset, we found a 1.64-point difference in pain scores from the mean difference for 
two groups with the parameters mean = 1.26 and sd = 1.28 for the Carevix group and mean = 2.9 and sd = 2.88 for 
the Tenaculum group, but only had 44% power in that pilot sample. Assuming a similar pain score difference, 

 
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increasing our sample size in this trial to 100 patients (50 in each group), the power increases to 94% for detecting 
the same 1.64-point difference in pain scores.  
 
In the pilot trial, we assessed pain scores at only 2 points: at cervix grasping and at completion of the procedure.  
In the European trial, they analyzed pain at 7 different points during the procedure.  We will expand our pain 
assessment to include: at baseline (prior to any examination or procedure and expectation of pain), at cervix 
grasping, at cervix traction, and at completion of the procedure. This study will utilize the NRS pain scale, a pain 
screening tool commonly used to assess pain severity at that moment in time using a 0–10 scale, with zero 
meaning “no pain” and 10 meaning “the worst pain imaginable”.8 The patient will be asked their baseline pain 
score (0-10) prior to getting undressed for the procedure, they will be asked their expectation for pain at this time 
as well, and then the provider will ask the patient's pain score at cervix grasping with either the device or 
tenaculum, and at cervix traction prior to IUD insertion.  The patient will then fill out their own pain score only at 
conclusion of the procedure after they have gotten dressed while they are filling out their survey questions. 
Following completion of their procedure, the patient will fill out the survey (attached) asking their demographics 
and about their experience, which takes about 1-2 minute to complete.  The provider performing the procedure 
will finish the survey with provider-specific questions about bleeding, ease of use and satisfaction. The purpose of 
this study is to compare Carevix™ to the tenaculum and determine if the Carevix™ shows similar results in the 
United States population as it has in the European study and with IUD insertions. 
Flow diagram for randomized study 
Prior to enrollment    
 
 
Enrollment 
 
 
 
 
 
Total N 100: Screen potential participants by inclusion 
criteria.  Obtain informed consent.  Obtain history.  
Document.  Randomize 
Randomized to Tenaculum arm 
Randomized to Carevix™ arm 
No cervical stabilization 
required or excluded: still fills 
out survey 
Receives tenaculum 
Receives Carevix™ if no 
exclusion criteria are met 

 
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6.0 Enrollment 
We intend to enroll one hundred patients who are presenting for IUD insertion at participating IU Health clinics 
throughout the state of Indiana. All patients presenting for IUD insertion to participating clinics at IU Health who 
meet inclusion criteria will be approached for this study. If a randomized participant has a post-randomization 
exclusion, most likely due to a listed cervical condition or anomaly on the exclusion list, they will be replaced with 
a new recruit but accounted for in the total enrolled participant report. 
7.0 Study Procedures 
IUD insertions already scheduled will otherwise proceed accordingly as part of clinical care. During the 
enrollment, patients who fit above inclusion criteria and are scheduled for an IUD insertion will be approached 
about this study and guided through an informed consent process and provided with a copy of their signed ICF 
during the recruitment period.  
Following completion of the procedure, the patient will then fill out the patient-based survey.  Following the 
completion of the patient’s questions, the provider will then fill out the provider-based survey. 
The survey will be done on paper and entered into REDCap as a secondary source for documentation for HIPAA 
and FDA 21 CFR Part 11 compliance and data security. 
8.0 Study Calendar/Timeline/Use of results 
There is no specific study calendar – the patient will have their IUD procedure scheduled and will decide if they 
wish to participate in this randomized trial or not.  The event will be a one-time procedure only occurring during 
and immediately after their IUD insertion procedure.  There will be no follow-up planned. 
Fills out tenaculum survey after 
procedure 
Fills out Carevix™ survey after 
procedure 
Provider fills out provider portion 
of survey after participant 
Once 100 patient surveys 
collected, end study 

 
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The timeline is that recruitment will start shortly after funding is granted, and we anticipate less than 1 year for 
study recruitment completion. 
The intention of this project is to determine if the use of Carevix makes IUD insertions less painful than using the 
standard tenaculum.  
9.0 Reportable Events 
It is not anticipated that there will be Serious Adverse Effects as defined by the FDA (death, life-threatening 
complications, need for hospitalization, disability or permanent damage, or an intervention needed to prevent 
permanent impairment or damage). However, if one occurs, it will be promptly reported to the IU IRB and 
sponsor (within 5 days of knowing about the occurrence) and per IU HRPP policy if unexpected, related/possibly 
related to participation and if the SAE suggests that the research places the subject or others at greater risk of 
harm. Study staff will document adverse events and the Principal Investigator will assess whether they are 
anticipated, related or possibly related to the procedure, and placed subjects at greater risk of harm.  All 
unanticipated adverse device effects (serious and not serious) will be promptly reported to the IU IRB. 
Other adverse events (AE) that may occur with any cervical stabilization device, such as bleeding or injury at 
stabilization site needing medication or surgical intervention, are uncommon and will be collected and reported as 
part of study data and at annual regulatory reviews. In the European trial, providers reported no bleeding in 89% 
(42 of 48) of subjects compared to tenaculum (40% or 21 of 52). Bruising was more common in the Carevix™ 
group (16%, or 8 of 48 participants), and no bleeding events required more than management with silver nitrate. 
Definition of an adverse event for bleeding will be: requiring any intervention beyond direct pressure or silver 
nitrate (such as suturing). 
10.0 
Data Safety Monitoring 
This study is no greater than minimal risk. Data safety and monitoring will be performed by the database manager 
for the REDCap database and the PI. Data quality, subject recruitment data completion, outcome and adverse 
event data, and proper consent procedures will be regularly reviewed by the PI, study coordinator, and data 
manager at least monthly. A formal Data Safety Monitoring Board is not required. While no formal stopping 
criteria are proposed, monitoring of AEs will be ongoing and will be discussed by the PI and Department 
representatives if the AE rate (notably bleeding or injury to the stabilization site on the cervix) is above 50%. 
11.0 
Study Withdrawal/Discontinuation 
Patients can decline participation and will receive standard of care (tenaculum) if cervical stabilization is required. 
Patients who consent to participate in the randomization trial and who require no cervical stabilization or are 

 
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assessed by the provider to be otherwise ineligible for the device will be considered ineligible and will still be 
asked to fill out the survey as per intention-to-treat analysis.  
12.0 
Statistical Considerations 
We performed sample size/power calculations with the primary outcome of pain (visual analog scale) at the time 
of Carevix™/tenaculum use. For our pilot study analysis, we used the Wilcoxon test instead of the t-test because 
the data were not normally distributed, with generally left shifted data (lower pain scores). Since the Wilcoxon 
test does not rely on the normality assumption, we used a simulation approach to estimate the power rather than 
the t-test power analysis. With the pilot trial dataset, we have 44% power to detect a 1.64-point difference in pain 
scores. If we increase the sample size to 100 patients (50 in each group), the power increases to 94% for detecting 
the same 1.64-point difference in pain scores.  We conducted our power simulation in R using a lognormal 
distribution to approximate the distributions we observed in our pilot data. We used rlnorm() with the 
parameters mean = 1.26 and sd = 1.28 for the Carevix group and mean = 2.9 and sd = 2.88 for the Tenaculum 
group. We generated 50 samples per group for each iteration, performed a Wilcoxon test at α = 0.05, and 
repeated this process 10000 times. The proportion of simulations with p < 0.05 was then used to estimate the 
empirical power. This will be the basis for our current analysis. 
Descriptive characteristics of those in the Carevix™ and control groups will be compared using standard statistical 
testing such as Chi-square and t-tests. We will once again assess for normality of the data in this study and will use 
appropriate tests for comparisons, such as the Wilcoxon, as we did in the pilot study. We anticipate the need for 
using nonparametric testing. Our department has a partnership with the Department of Biostatisics, who assisted 
with the pilot analysis, this sample size calculation, and will be responsible for the randomization scheme and 
ultimately the final data analyses. They will utilize R for their data analysis. Differences in outcomes between the 
device and control groups will similarly utilize standard testing. We will compare the subgroups of nulliparous and 
parous participants separately to assess for possible differences in two groups, similar to what was seen in the 
European study. We will examine some covariates to assess their potential effects in both groups. For continuous 
outcomes, such as pain score, we plan to use the generalized linear model (GLM). This method allows us to 
evaluate the main effects or potential interaction effects on the outcome. While we anticipate that randomization 
will lead to similar demographic characteristics in both Carevix and tenaculum groups, if significant differences 
occur by chance, we will consider other adjusted analyses as needed.  
13.0 
Statistical Data Management 
Individual research data will not be made available to the clinical care provider. Primary data will be collected via 
paper surveys and then electronically stored in REDCap, SAS files, and excel spreadsheets on encrypted secure 
servers. Quality assurance steps may include: 1) built in range check; 2) defined user definitions; and, 3) testing of 

 
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database integrity by study team members prior to commencing statistical analyses. The following quality control 
methods will be used: 1) single entry, with random checks of accuracy; and, 2) extraction and cleaning of data that 
will be used for analysis as needed. Survey data collection will be done in person via paper surveys.  Consenting 
will occur in person on paper ICFs and CRFs in a private room. The signed consent forms will be stored in a secure 
and lockable cabinet. 
14.0 
Privacy/Confidentiality Issues 
This is a comparative effectiveness trial posing no more than minimal risk of loss of privacy and confidentiality. 
Consent will occur in person during gynecological clinical visits. All participants will be assigned a unique 
participant ID number to link patient and provider questionnaires. Paper documents will be stored in a lockable 
file cabinet within a locked room with limited access to qualified members of the research team. None of the 
questions on the data collection questionnaire will contain PHI. Study questionnaires will be administered in 
person via paper surveys and then stored electronically on REDCap during a gynecological clinical visit within a 
private area. Data will be stored in a lockable cabinet and electronically on REDCap. Study outcomes (abstracts, 
presentations, publications, media interviews, etc.) will use only aggregate data, and will not disclose individual 
participant data. 
15.0 
Follow-up and Record Retention 
 
The study will last about 1 year.  We will keep the data in accordance with the IU HRPP policy on research data 
management.   
16.0 
References 
 
1. Akdemir, Y., & Karadeniz, M. The relationship between pain at IUD insertion and negative perceptions, 
anxiety and previous mode of delivery. The European Journal of Contraception & Reproductive Health 
Care, 24(3), 2019, 240–245. 
 
2. Curtis K, Nguyen A, et al.  U.S. Selected Practice Recommendations for Contraceptive Use, 
2024.  Recommendations and Reports / August 8, 2024 / 73(3);1–77 
 
3. Yaron M, et al.  Safety and efficacy of a suction cervical stabilizer for intrauterine contraceptive device 
insertion: Results from a randomized, controlled study.  Contraception.  Vol 123, July 2023. 
https://www.contraceptionjournal.org/article/S0010-7824(23)00066-5/fulltext 
 
4. Tegan A. Hunter, Sarita Sonalkar, Courtney A. Schreiber, Lisa K. Perriera, Mary D. Sammel, Aletha Y. Akers. 
Anticipated Pain During Intrauterine Device Insertion. Journal of Pediatric and Adolescent Gynecology. 
Volume 33, Issue 1, 2020, Pages 27-32. 
 
5. Edwards, Sara; Mercier, Rebecca MD; Perriera, Lisa MD, MPH. Do Patient Attitudes About the Intrauterine 
Device Differ Based on Race and Ethnicity? [6G]. Obstetrics & Gynecology 131: 2018, p 76S. 
 

 
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6. Narayan, AEvans, S et al. Does the expectation of pain with intrauterine device (IUD) insertion differ 
between those who initiate IUD and those who do not? A survey of adolescents and young adult women. 
Contraception, Volume 94, Issue 4, 2016, 408. 
 
7. Estevez E, Hem-Lee-Forsyth S, Viechweg N, John S, Menor SP. Advancing Pain Management Protocols for 
Intrauterine Device Insertion: Integrating Evidence-Based Strategies Into Clinical Practice. Cureus. 
2024;16(6):e63125. 
 
8. Jensen, Mark P.*; Karoly, Paul*; O'Riordan, Eoghan F.†; Bland, Frank Jr.†; Burns, Ronald S.†. The 
Subjective Experience of Acute Pain An Assessment of the Utility of 10 Indices. The Clinical Journal of Pain 
5(2):p 153-160, June 1989. 
1.0 
Appendix 
Attachment #1: Aspivix company brochure on Carevix™ 
Attachment #2: Carevix™ data published in the journal Contraception. 
Attachment #3: Questionnaire for patients and providers (done through the same link). 
Attachment #4: Study information sheet and consent form. 
Attachment #5: Our pilot data from 2024 trial on all intrauterine procedures 
Attachment #6: CDC updated recommendations for pain management during IUD insertion 8.8.24